Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators

Recall number

Z-1788-2023

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Product

CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators

Status

Open, Classified

Initiated

2023-05-10

Posted

2023-06-16

Terminated

not on file

Reason

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Root cause

Under Investigation by firm

Action

Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

Quantity

2142 units

Distribution

US Nationwide - Worldwide Distribution

Lot, serial or model codes

GTIN 00763000178253, Lot Serial Numbers: RTS600109S, RTS600115S, RTS600751S, RTS600754S, RTS600962S, RTS600827S, RTS600976S, RTS600761S, RTS600116S, RTS600128S, RTS600174S, RTS600280S, RTS600285S, RTS600674S, RTS600094S, RTS600271S, RTS600277S, RTS600961S, RTS600987S, RTS601452S, RTS600164S, RTS600168S, RTS600203S, RTS600209S, RTS600222S, RTS600375S, RTS600636S, RTS600652S, RTS600734S, RTS600800S, RTS600876S, RTS600127S, RTS600189S, RTS600170S, RTS600171S, RTS600251S, RTS600459S, RTS600460S, RTS600464S, RTS600537S, RTS600608S, RTS600792S, RTS601104S, RTS601108S, RTS600087S, RTS600091S, RTS601032S, RTS600079S, RTS600080S, RTS600081S, RTS600083S, RTS600119S, RTS600161S, RTS600255S, RTS600258S, RTS600261S, RTS600316S, RTS600322S, RTS600418S, RTS600812S, RTS601439S, RTS601440S, RTS601454S, RTS600198S, RTS600744S, RTS600831S, RTS600843S, RTS600963S, RTS600984S, RTS600989S, RTS601015S, RTS601016S, RTS601434S, RTS601436S, RTS602647S, RTS600836S, RTS600092S, RTS600135S, RTS600136S, RTS600137S, RTS600172S, RTS600181S, RTS600224S, RTS600231S, RTS600246S, RTS600256S, RTS600264S, RTS600342S, RTS600377S, RTS600384S, RTS600385S, RTS600398S, RTS600399S, RTS600424S, RTS600430S, RTS600435S, RTS600442S, RTS600470S, RTS600599S, RTS600621S, RTS600622S, RTS600649S, RTS600668S, RTS600738S, RTS600770S, RTS600775S, RTS600780S, RTS600788S, RTS600832S, RTS600854S, RTS600861S, RTS600793S, RTS600893S, RTS601084S, RTS601095S, RTS602634S, RTS600073S, RTS600133S, RTS600156S, RTS600159S, RTS600169S, RTS600178S, RTS600202S, RTS600332S, RTS600382S, RTS600735S, RTS600803S, RTS600878S, RTS600879S, RTS600899S, RTS600977S, RTS600982S, RTS600992S, RTS600841S, RTS600882S, RTS600972S, RTS601094S, RTS600433S, RTS600632S, RTS600709S, RTS600711S, RTS600760S, RTS600764S, RTS600801S, RTS600805S, RTS600806S, RTS600835S, RTS600129S, RTS600457S, RTS600465S, RTS600468S, RTS600625S, RTS600626S, RTS600644S, RTS600645S, RTS600646S, RTS600647S, RTS600657S, RTS600659S, RTS600660S, RTS600681S, RTS600708S, RTS600724S, RTS600726S, RTS600740S, RTS600797S, RTS600799S, RTS600819S, RTS600822S, RTS600830S, RTS600839S, RTS600844S, RTS600845S, RTS600862S, RTS600863S, RTS600869S, RTS600870S, RTS600871S, RTS600872S, RTS600873S, RTS600877S, RTS600902S, RTS600904S, RTS600951S, RTS600952S, RTS601037S, RTS601069S, RTS601072S, RTS601073S, RTS601074S, RTS601075S, RTS601076S, RTS601077S, RTS601078S, RTS601083S, RTS601085S, RTS601088S, RTS601089S, RTS601092S, RTS601093S, RTS601097S, RTS601099S, RTS601411S, RTS601412S, RTS601413S, RTS601415S, RTS601417S, RTS601418S, RTS601445S, RTS601447S, RTS601448S, RTS600146S, RTS600462S, RTS601407S, RTS600745S, RTS600746S, RTS600829S, RTS600393S, RTS600782S, RTS600986S, RTS600101S, RTS600602S, RTS600603S, RTS600703S, RTS600834S, RTS600837S, RTS600856S, RTS600858S, RTS600859S, RTS600865S, RTS600990S, RTS601018S, RTS601033S, RTS601106S, RTS601392S, RTS601395S, RTS600423S, RTS600071S, RTS600219S, RTS600701S, RTS600766S, RTS601399S, RTS600012S, RTS601222S, RTS601245S, RTS600104S, RTS600196S, RTS600090S, RTS600140S, RTS600232S, RTS600472S, RTS600473S, RTS600666S, RTS600718S, RTS600722S, RTS600727S, RTS600887S, RTS600890S, RTS600978S, RTS600980S, RTS600988S, RTS601450S, RTS601451S, RTS600686S, RTS602637S, RTS600076S, RTS600205S, RTS600376S, RTS600635S, RTS600654S, RTS600971S, RTS601079S, RTS601162S, RTS601401S, RTS600723S, RTS600757S, RTS600122S, RTS600155S, RTS600166S, RTS600167S, RTS600363S, RTS600397S, RTS600810S, RTS600850S, RTS601462S, RTS600432S, RTS600162S, RTS600243S, RTS600365S, RTS600445S, RTS600067S, RTS600068S, RTS600072S, RTS600074S, RTS600077S, RTS600085S, RTS600099S, RTS600110S, RTS600112S, RTS600113S, RTS600117S, RTS600121S, RTS600124S, RTS600126S, RTS600139S, RTS600147S, RTS600148S, RTS600149S, RTS600150S, RTS600179S, RTS600185S, RTS600194S, RTS600206S, RTS600233S, RTS600238S, RTS600239S, RTS600248S, RTS600253S, RTS600259S, RTS600307S, RTS600370S, RTS600420S, RTS600427S, RTS600429S, RTS600444S, RTS600446S, RTS600454S, RTS600455S, RTS600467S, RTS600469S, RTS600609S, RTS600619S, RTS600620S, RTS600627S, RTS600633S, RTS600634S, RTS600641S, RTS600655S, RTS600658S, RTS600682S, RTS600688S, RTS600690S, RTS600714S, RTS600715S, RTS600796S, RTS600808S, RTS600826S, RTS600875S, RTS600970S, RTS600975S, RTS601080S, RTS601081S, RTS601096S, RTS601102S, RTS601114S, RTS601404S, RTS601408S, RTS601416S, RTS600163S, RTS600165S, RTS600183S, RTS600191S, RTS600270S, RTS600717S, RTS600903S, RTS600097S, RTS600145S, RTS600752S, RTS600784S, RTS600823S, RTS601409S, RTS600707S, RTS601011S, RTS600814S, RTS600197S, RTS600283S, RTS600431S, RTS600458S, RTS600787S, RTS600855S, RTS600240S, RTS601109S, RTS600691S, RTS600768S, RTS600783S, RTS600631S, RTS600208S, RTS600392S, RTS600664S, RTS600273S, RTS600276S, RTS600748S, RTS600807S, RTS600199S, RTS600379S, RTS600402S, RTS600624S, RTS600678S, RTS600680S, RTS600204S, RTS600604S, RTS600695S, RTS600795S, RTS600815S, RTS600817S, RTS600825S, RTS600848S, RTS600964S, RTS600966S, RTS601153S, RTS601478S, RTS601482S, RTS600684S, RTS600781S, RTS600816S, RTS600820S, RTS600881S, RTS600953S, RTS601013S, RTS601384S, RTS601477S, RTS600193S, RTS600200S, RTS600207S, RTS600215S, RTS600216S, RTS600220S, RTS600221S, RTS600223S, RTS600225S, RTS600226S, RTS600227S, RTS600237S, RTS600244S, RTS600245S, RTS600250S, RTS600254S, RTS600260S, RTS600262S, RTS600269S, RTS600741S, RTS600742S, RTS600774S, RTS600776S, RTS600777S, RTS600778S, RTS600779S, RTS600905S, RTS600942S, RTS600946S, RTS600954S, RTS600974S, RTS601713S, RTS601720S, RTS601721S, RTS600082S, RTS600089S, RTS600093S, RTS600131S, RTS600153S, RTS600182S, RTS600290S, RTS600769S, RTS600771S, RTS600773S, RTS601389S, RTS601498S, RTS601500S, RTS601504S, RTS601507S, RTS601512S, RTS601516S, RTS601519S, RTS601521S, RTS601532S, RTS601534S, RTS601537S, RTS601541S, RTS601542S, RTS601543S, RTS601544S, RTS601548S, RTS601553S, RTS601555S, RTS601556S, RTS601558S, RTS601562S, RTS601563S, RTS601564S, RTS601567S, RTS601684S, RTS601722S, RTS601723S, RTS601724S, RTS601725S, RTS601726S, RTS601727S, RTS601728S, RTS601729S, RTS601730S, RTS601731S, RTS601732S, RTS601733S, RTS601734S, RTS601735S, RTS601737S, RTS601738S, RTS601739S, RTS601740S, RTS601741S, RTS601742S, RTS601743S, RTS601744S, RTS601745S, RTS601746S, RTS601747S, RTS601748S, RTS601749S, RTS601750S, RTS601751S, RTS601752S, RTS601753S, RTS601754S, RTS601755S, RTS601756S, RTS601757S, RTS601758S, RTS601760S, RTS601761S, RTS601762S, RTS601763S, RTS601764S, RTS601765S, RTS601766S, RTS601767S, RTS601768S, RTS601769S, RTS601770S, RTS601771S, RTS601774S, RTS601776S, RTS602070S, RTS602075S, RTS602076S, RTS602077S, RTS602078S, RTS602084S, RTS602092S, RTS602093S, RTS602109S, RTS602110S, RTS602115S, RTS602116S, RTS602117S, RTS602118S, RTS602127S, RTS602142S, RTS602146S, RTS602149S, RTS602152S, RTS602154S, RTS602159S, RTS602160S, RTS602161S, RTS602162S, RTS602165S, RTS602166S, RTS602168S, RTS602169S, RTS602170S, RTS602171S, RTS602172S, RTS602173S, RTS602174S, RTS602176S, RTS602177S, RTS602179S, RTS602180S, RTS602183S, RTS602184S, RTS602185S, RTS602205S, RTS602206S, RTS602207S, RTS602221S, RTS602223S, RTS602224S, RTS602225S, RTS602227S, RTS602287S, RTS602288S, RTS602289S, RTS602290S, RTS602291S, RTS602292S, RTS602293S, RTS602294S, RTS602295S, RTS602296S, RTS602297S, RTS602298S, RTS602300S, RTS602302S, RTS602303S, RTS602304S, RTS602305S, RTS602306S, RTS602307S, RTS602308S, RTS602309S, RTS602311S, RTS602312S, RTS602315S, RTS602316S, RTS602317S, RTS602318S, RTS602319S, RTS602320S, RTS602321S, RTS602322S, RTS602323S, RTS602324S, RTS602325S, RTS602326S, RTS602327S, RTS602328S, RTS602329S, RTS602330S, RTS602396S, RTS602428S, RTS602429S, RTS602433S, RTS602436S, RTS602486S, RTS602537S, RTS602538S, RTS602539S, RTS602541S, RTS602542S, RTS602543S, RTS602544S, RTS602545S, RTS602546S, RTS602547S, RTS602548S, RTS602551S, RTS602556S, RTS602557S, RTS602559S, RTS602562S, RTS602564S, RTS602565S, RTS602567S, RTS602570S, RTS602571S, RTS602572S, RTS602573S, RTS602574S, RTS602575S, RTS602576S, RTS602577S, RTS602579S, RTS602580S, RTS602583S, RTS602584S, RTS602591S, RTS602592S, RTS602593S, RTS602597S, RTS602602S, RTS602603S, RTS602607S, RTS602610S, RTS602611S, RTS602612S, RTS602615S, RTS602616S, RTS602617S, RTS602618S, RTS602621S, RTS602635S, RTS602636S, RTS602638S, RTS602639S, RTS602642S, RTS602644S, RTS602645S, RTS602646S, RTS601718S, RTS601719S, RTS600956S, RTS600958S, RTS600108S, RTS600151S, RTS600791S, RTS600739S, RTS600798S, RTS600868S, RTS600381S, RTS600828S, RTS600985S, RTS600728S, RTS600630S, RTS600102S, RTS600103S, RTS600449S, RTS600756S, RTS601014S, RTS601031S, RTS601393S, RTS601437S, RTS600236S, RTS600618S, RTS600689S, RTS600731S, RTS600785S, RTS600789S, RTS600853S, RTS600894S, RTS601005S, RTS601023S, RTS601030S, RTS600704S, RTS600710S, RTS600712S, RTS600765S, RTS600772S, RTS600809S, RTS601090S, RTS600692S, RTS602193S, RTS600125S, RTS600157S, RTS600158S, RTS600241S, RTS600242S, RTS600249S, RTS600252S, RTS600263S, RTS600289S, RTS600391S, RTS600628S, RTS600696S, RTS600736S, RTS600759S, RTS600811S, RTS600864S, RTS601386S, RTS601004S, RTS600847S, RTS600123S, RTS600288S, RTS600389S, RTS600461S, RTS600672S, RTS600737S, RTS600794S, RTS600813S, RTS600867S, RTS601385S, RTS600716S, RTS600594S, RTS600287S, RTS600471S, RTS600396S, RTS600653S, RTS600662S, RTS600762S, RTS600965S, RTS600981S, RTS600436S, RTS600437S, RTS600456S, RTS600685S, RTS600860S, RTS600895S, RTS600979S, RTS600994S, RTS601025S, RTS601026S, RTS601027S, RTS601388S, RTS600291S, RTS600733S, RTS600758S, RTS600818S, RTS600095S, RTS600400S, RTS600428S, RTS600702S, RTS600786S, RTS601028S, RTS601391S, RTS600387S, RTS601398S, RTS600160S, RTS600906S, RTS600907S, RTS600851S, RTS600601S, RTS600257S, RTS600434S, RTS600683S, RTS600891S, RTS601068S, RTS600670S, RTS600729S, RTS600767S, RTS600968S, RTS601432S, RTS600896S, RTS600898S, RTS602623S, RTS602549S, RTS600732S, RTS601456S, RTS600721S, RTS601443S, RTS600463S, RTS601457S, RTS600790S, RTS600615S, RTS600175S, RTS600176S, RTS600201S, RTS600210S, RTS600211S, RTS600212S, RTS600217S, RTS600218S, RTS600272S, RTS600612S, RTS600613S, RTS600614S, RTS600749S, RTS600750S, RTS600755S, RTS600892S, RTS600084S, RTS600088S, RTS600347S, RTS600152S, RTS600154S, RTS600386S, RTS600617S, RTS600747S, RTS600763S, RTS600838S, RTS600983S, RTS601461S, RTS601474S, RTS600743S, RTS600141S, RTS600969S, RTS600214S, RTS602608S, RTS602609S, RTS602600S; GTIN 00763000178277, Lot Serial numbers: RTS602089S, RTS602629S, RTS602219S, RTS602229S, RTS602122S, RTS602937S, RTS602798S, RTS603142S, RTS602680S, RTS603044S, RTS603140S, RTS603128S, RTS603107S, RTS602713S, RTS603098S, RTS602450S, RTS601783S, RTS603094S, RTS601887S, RTS602462S, RTS602504S, RTS600293S, RTS600358S, RTS600846S, RTS600504S, RTS601156S, RTS601157S, RTS600532S, RTS600541S, RTS601206S, RTS600833S, RTS601396S, RTS602818S, RTS601695S, RTS601710S, RTS601165S, RTS602866S, RTS603041S, RTS600490S, RTS600563S, RTS600564S, RTS601049S, RTS601465S, RTS601481S, RTS602087S, RTS602695S, RTS601038S, RTS601675S, RTS602472S, RTS601842S, RTS602863S, RTS600311S, RTS600663S, RTS601873S, RTS601888S, RTS602732S, RTS600499S, RTS601203S, RTS601855S, RTS602163S, RTS602683S, RTS602700S, RTS600651S, RTS601144S, RTS601169S, RTS601475S, RTS601670S, RTS601672S, RTS601673S, RTS601685S, RTS601839S, RTS601879S, RTS602479S, RTS602712S, RTS602794S, RTS601177S, RTS602786S, RTS600650S, RTS601125S, RTS601227S, RTS601508S, RTS601883S, RTS602507S, RTS602510S, RTS602640S, RTS602697S, RTS602820S, RTS602867S, RTS600441S, RTS601163S, RTS601674S, RTS601709S, RTS601890S, RTS602420S, RTS602733S, RTS602814S, RTS600565S, RTS600581S, RTS601164S, RTS601171S, RTS601217S, RTS601223S, RTS601231S, RTS602451S, RTS602627S, RTS602654S, RTS602775S, RTS602861S, RTS602862S, RTS601467S, RTS603068S, RTS603069S, RTS603075S, RTS601213S, RTS601714S, RTS602776S, RTS601225S, RTS602679S, RTS600883S, RTS600926S, RTS600927S, RTS601101S, RTS601107S, RTS601111S, RTS601112S, RTS601113S, RTS601158S, RTS601181S, RTS601215S, RTS601224S, RTS601244S, RTS601473S, RTS601503S, RTS601687S, RTS601821S, RTS601864S, RTS601880S, RTS602188S, RTS602408S, RTS602409S, RTS602494S, RTS602633S, RTS602692S, RTS602873S, RTS602232S, RTS600296S, RTS600302S, RTS600315S, RTS600333S, RTS601133S, RTS602492S, RTS600373S, RTS600489S, RTS600562S, RTS601134S, RTS601228S, RTS601539S, RTS601705S, RTS601829S, RTS602437S, RTS602464S, RTS602516S, RTS600520S, RTS600026S, RTS600543S, RTS600567S, RTS600578S, RTS601055S, RTS601087S, RTS601202S, RTS601789S, RTS601819S, RTS602468S, RTS600505S, RTS600639S, RTS600921S, RTS601053S, RTS601059S, RTS601182S, RTS601187S, RTS601405S, RTS601428S, RTS601441S, RTS601460S, RTS601479S, RTS601700S, RTS601701S, RTS601784S, RTS601785S, RTS601786S, RTS601793S, RTS601794S, RTS601823S, RTS601824S, RTS601854S, RTS601874S, RTS601891S, RTS602124S, RTS602131S, RTS602155S, RTS602156S, RTS602157S, RTS602399S, RTS602401S, RTS602405S, RTS602406S, RTS602413S, RTS602415S, RTS602734S, RTS602809S, RTS602837S, RTS602878S, RTS601204S, RTS601230S, RTS601471S, RTS602091S, RTS602484S, RTS600356S, RTS600517S, RTS600526S, RTS600568S, RTS600570S, RTS600574S, RTS600586S, RTS600611S, RTS600616S, RTS600676S, RTS600693S, RTS600920S, RTS601034S, RTS601105S, RTS601180S, RTS601406S, RTS601425S, RTS601442S, RTS601843S, RTS601421S, RTS601422S, RTS601423S, RTS601424S, RTS600576S, RTS601431S, RTS600531S, RTS601805S, RTS600529S, RTS600597S, RTS600607S, RTS600610S, RTS600637S, RTS600687S, RTS601809S, RTS602132S, RTS602417S, RTS601804S, RTS601834S, RTS601835S, RTS601844S, RTS602978S, RTS601000S, RTS601188S, RTS601226S, RTS601694S, RTS600706S, RTS600842S, RTS600928S, RTS600949S, RTS601414S, RTS601858S, RTS601871S, RTS602145S, RTS602187S, RTS602480S, RTS602532S, RTS602536S, RTS602802S, RTS602883S, RTS600556S, RTS601468S, RTS601862S, RTS602398S, RTS602410S, RTS602501S, RTS602630S, RTS602649S, RTS602947S, RTS603053S, RTS600916S, RTS601029S, RTS601229S, RTS600301S, RTS602499S, RTS602508S, RTS602687S, RTS602688S, RTS602693S, RTS602708S, RTS602781S, RTS602874S, RTS600509S, RTS600525S, RTS600527S, RTS600528S, RTS600530S, RTS600577S, RTS600667S, RTS601420S, RTS601525S, RTS601716S, RTS602552S, RTS602204S, RTS601064S, RTS601131S, RTS601132S, RTS601137S, RTS601875S, RTS602445S, RTS601546S, RTS601549S, RTS601704S, RTS601707S, RTS601708S, RTS601711S, RTS602412S, RTS602518S, RTS602684S, RTS600354S, RTS600355S, RTS600501S, RTS600512S, RTS600533S, RTS601117S, RTS601463S, RTS601677S, RTS602139S, RTS602151S, RTS602881S, RTS603091S, RTS600583S, RTS600513S, RTS600516S, RTS600542S, RTS600573S, RTS600575S, RTS600677S, RTS600918S, RTS601200S, RTS601811S, RTS601816S, RTS602186S, RTS602418S, RTS602441S, RTS602444S, RTS602465S, RTS602493S, RTS602723S, RTS602777S, RTS602779S, RTS602932S, RTS602404S, RTS600584S, RTS601825S, RTS601869S, RTS602714S, RTS600228S, RTS600274S, RTS600312S, RTS600353S, RTS600852S, RTS600932S, RTS601808S, RTS603018S, RTS601039S, RTS602722S, RTS602806S, RTS600494S, RTS600675S, RTS600930S, RTS601098S, RTS601210S, RTS601426S, RTS601511S, RTS601715S, RTS601179S, RTS600606S, RTS601430S, RTS601827S, RTS601100S, RTS602175S, RTS602513S, RTS602533S, RTS602717S, RTS602960S, RTS600605S, RTS601190S, RTS601837S, RTS602702S, RTS600037S, RTS602214S, RTS602432S, RTS602526S, RTS600300S, RTS600310S, RTS600317S, RTS601857S, RTS602106S, RTS601201S, RTS602125S, RTS600321S, RTS600323S, RTS600325S, RTS600326S, RTS600327S, RTS600960S, RTS601400S, RTS601402S, RTS600029S, RTS600030S, RTS600036S, RTS600041S, RTS600042S, RTS600043S, RTS600305S, RTS600502S, RTS600511S, RTS600559S, RTS600929S, RTS601036S, RTS601071S, RTS601175S, RTS601483S, RTS601531S, RTS601697S, RTS601699S, RTS601777S, RTS602460S, RTS602774S, RTS602880S, RTS601806S, RTS600515S, RTS600588S, RTS600912S, RTS600534S, RTS600643S, RTS600629S, RTS601815S, RTS601397S, RTS601551S, RTS601678S, RTS602400S, RTS602997S, RTS603002S, RTS601818S, RTS601211S, RTS601427S, RTS601812S, RTS600497S, RTS600498S, RTS600521S, RTS600535S, RTS600936S, RTS601433S, RTS601538S, RTS601813S, RTS601814S, RTS601853S, RTS601884S, RTS602088S, RTS602138S, RTS602477S, RTS602498S, RTS602515S, RTS602650S, RTS602782S, RTS602922S, RTS600536S, RTS600915S, RTS600919S, RTS600925S, RTS600959S, RTS601176S, RTS601198S, RTS601847S, RTS602478S, RTS603110S, RTS602651S, RTS602735S, RTS601540S, RTS602506S, RTS602690S, RTS600346S, RTS601535S, RTS601686S, RTS602416S, RTS602422S, RTS602463S, RTS602469S, RTS602473S, RTS602868S, RTS601682S, RTS601831S, RTS602201S, RTS600348S, RTS600484S, RTS600485S, RTS600486S, RTS600487S, RTS602419S, RTS601787S, RTS602821S, RTS602865S, RTS601466S, RTS601040S, RTS600524S, RTS601167S, RTS601193S, RTS601419S, RTS601115S, RTS600492S, RTS600582S, RTS600596S, RTS600720S, RTS601017S, RTS601061S, RTS601070S, RTS602461S, RTS601118S, RTS600343S, RTS601121S, RTS601859S, RTS601860S, RTS601861S, RTS601192S, RTS600924S, RTS601429S, RTS601472S, RTS601717S, RTS601797S, RTS602097S, RTS602459S, RTS602790S, RTS602805S, RTS602879S, RTS600508S, RTS600957S, RTS601550S, RTS601781S, RTS601782S, RTS602447S, RTS602452S, RTS602481S, RTS602500S, RTS602736S, RTS602737S, RTS602738S, RTS602739S, RTS602740S, RTS602741S, RTS602742S, RTS602743S, RTS602744S, RTS602745S, RTS602746S, RTS602747S, RTS602748S, RTS602749S, RTS602750S, RTS602751S, RTS602752S, RTS602753S, RTS602754S, RTS602755S, RTS602756S, RTS602757S, RTS602758S, RTS602759S, RTS602760S, RTS602761S, RTS602762S, RTS602763S, RTS602764S, RTS602765S, RTS602766S, RTS602767S, RTS602768S, RTS602769S, RTS602770S, RTS602210S, RTS602446S, RTS602470S, RTS602521S, RTS602529S, RTS602632S, RTS602482S, RTS602823S, RTS601241S, RTS601403S, RTS601470S, RTS601779S, RTS601803S, RTS601832S, RTS601848S, RTS601849S, RTS601852S, RTS601886S, RTS602100S, RTS602167S, RTS602457S, RTS602458S, RTS602496S, RTS602511S, RTS602512S, RTS602707S, RTS602721S, RTS602771S, RTS602800S, RTS602944S, RTS602832S, RTS602833S, RTS602456S, RTS602483S, RTS602497S, RTS602525S, RTS602561S, RTS602601S, RTS602727S, RTS602423S, RTS600369S, RTS600495S, RTS600506S, RTS600510S, RTS600522S, RTS600538S, RTS600555S, RTS600557S, RTS600569S, RTS600571S, RTS600638S, RTS600665S, RTS600671S, RTS600922S, RTS601022S, RTS601166S, RTS601170S, RTS601173S, RTS601174S, RTS601212S, RTS601236S, RTS601799S, RTS601800S, RTS601801S, RTS601802S, RTS601833S, RTS601856S, RTS601878S, RTS602094S, RTS602625S, RTS602698S, RTS602834S, RTS602876S, RTS603021S, RTS603023S, RTS603139S, RTS601600S, RTS601601S, RTS601603S, RTS601604S, RTS601605S, RTS601606S, RTS601607S, RTS601608S, RTS601609S, RTS601610S, RTS601611S, RTS601612S, RTS601613S, RTS601614S, RTS601615S, RTS601616S, RTS601617S, RTS601618S, RTS601619S, RTS601620S, RTS601622S, RTS601623S, RTS601624S, RTS601625S, RTS601626S, RTS601627S, RTS601628S, RTS601629S, RTS601630S, RTS601631S, RTS601632S, RTS601633S, RTS601634S, RTS601635S, RTS601637S, RTS601638S, RTS601639S, RTS601640S, RTS601641S, RTS601642S, RTS601643S, RTS601644S, RTS601645S, RTS601646S, RTS601647S, RTS601648S, RTS601649S, RTS601650S, RTS601651S, RTS601652S, RTS601653S, RTS601654S, RTS601655S, RTS601656S, RTS601657S, RTS601658S, RTS601659S, RTS601660S, RTS601661S, RTS601662S, RTS601663S, RTS601664S, RTS601666S, RTS601667S, RTS601669S, RTS600017S, RTS600018S, RTS600045S, RTS600063S, RTS600064S, RTS600329S, RTS600359S, RTS600493S, RTS600539S, RTS600540S, RTS600857S, RTS600900S, RTS601135S, RTS602112S, RTS601518S, RTS602178S, RTS600031S, RTS600032S, RTS600997S, RTS601186S, RTS600673S, RTS600679S, RTS600306S, RTS600313S, RTS600866S, RTS600897S, RTS601054S, RTS601063S, RTS600566S, RTS600998S, RTS601513S, RTS601882S, RTS600060S, RTS600281S, RTS600331S, RTS600518S, RTS600560S, RTS600698S, RTS600874S, RTS600889S, RTS601067S, RTS601122S, RTS600923S, RTS601150S, RTS601221S, RTS601865S, RTS601866S, RTS602725S, RTS600697S, RTS601060S, RTS600016S, RTS600044S, RTS600058S, RTS600344S, RTS600592S, RTS601130S, RTS601140S, RTS601159S, RTS601207S, RTS603056S, RTS601232S, RTS602822S, RTS601676S, RTS601790S, RTS601795S, RTS601820S, RTS601876S, RTS602164S, RTS602403S, RTS602485S, RTS602505S, RTS602569S, RTS602685S, RTS602726S, RTS602810S, RTS600275S, RTS600360S, RTS600700S, RTS600911S, RTS600931S, RTS600933S, RTS601168S, RTS601838S, RTS601867S, RTS602715S, RTS600572S, RTS601142S, RTS602150S, RTS602440S, RTS602720S, RTS600558S, RTS600880S, RTS600885S, RTS600910S, RTS601147S, RTS601151S, RTS601152S, RTS601199S, RTS601696S, RTS602147S, RTS602148S, RTS602489S, RTS602872S, RTS600014S, RTS600235S, RTS600295S, RTS600304S, RTS600308S, RTS600345S, RTS600349S, RTS600351S, RTS600503S, RTS600579S, RTS600908S, RTS600999S, RTS601001S, RTS601143S, RTS601216S, RTS601218S, RTS601219S, RTS601394S, RTS601476S, RTS601506S, RTS601691S, RTS601693S, RTS601830S, RTS601881S, RTS602474S, RTS602784S, RTS602101S, RTS602103S, RTS602104S, RTS602108S, RTS602111S, RTS602198S, RTS602235S, RTS602236S, RTS601045S, RTS601047S, RTS601357S, RTS601364S, RTS601458S, RTS602189S, RTS602943S, RTS600914S, RTS600937S, RTS600938S, RTS600939S, RTS600940S, RTS600941S, RTS600943S, RTS600944S, RTS600945S, RTS601003S, RTS601050S, RTS601051S, RTS601056S, RTS601057S, RTS601058S, RTS601062S, RTS601066S, RTS601119S, RTS601120S, RTS601127S, RTS601128S, RTS601160S, RTS601178S, RTS601191S, RTS601195S, RTS601197S, RTS601242S, RTS601350S, RTS601353S, RTS601359S, RTS601360S, RTS601361S, RTS601363S, RTS601366S, RTS601367S, RTS601446S, RTS601455S, RTS601499S, RTS601501S, RTS601502S, RTS601510S, RTS601514S, RTS601529S, RTS601530S, RTS601533S, RTS601545S, RTS601552S, RTS601557S, RTS601561S, RTS601566S, RTS602073S, RTS602074S, RTS602090S, RTS602105S, RTS601043S, RTS601044S, RTS601356S, RTS601365S, RTS602082S, RTS602096S, RTS602143S, RTS600884S, RTS601189S, RTS602803S, RTS601205S, RTS600330S, RTS600656S, RTS602402S, RTS600022S, RTS600352S, RTS600886S, RTS600917S, RTS601692S, RTS601702S, RTS601863S, RTS601872S, RTS602079S, RTS602233S, RTS602792S, RTS602801S, RTS602864S, RTS601235S, RTS600337S, RTS601234S, RTS601237S, RTS601238S, RTS601559S, RTS601560S, RTS601892S, RTS601893S, RTS600035S, RTS600286S, RTS600292S, RTS600491S, RTS601008S, RTS601041S, RTS601086S, RTS601208S, RTS600034S, RTS600303S, RTS600967S, RTS601138S, RTS601184S, RTS602107S, RTS600648S, RTS602797S, RTS600048S, RTS600514S, RTS600015S, RTS600038S, RTS600061S, RTS600309S, RTS600328S, RTS600425S, RTS600519S, RTS600587S, RTS600590S, RTS600719S, RTS600888S, RTS601065S, RTS601123S, RTS601136S, RTS600069S, RTS601846S, RTS602113S, RTS602114S, RTS600024S, RTS601126S, RTS601141S, RTS601183S, RTS602466S, RTS600585S, RTS600849S, RTS600580S, RTS601194S, RTS600600S, RTS600051S, RTS600053S, RTS600055S, RTS600284S, RTS600319S, RTS600320S, RTS600554S, RTS600661S, RTS600705S, RTS600913S, RTS601103S, RTS601116S, RTS601185S, RTS601209S, RTS601444S, RTS601449S, RTS601683S, RTS601698S, RTS601792S, RTS601807S, RTS601868S, RTS602102S, RTS602181S, RTS602182S, RTS602216S, RTS602434S, RTS602435S, RTS602448S, RTS602487S, RTS602699S, RTS602701S, RTS602719S, RTS602731S, RTS602772S, RTS602773S, RTS602827S, RTS602828S, RTS603005S, RTS603085S, RTS603087S, RTS601007S, RTS601009S, RTS601012S, RTS601019S, RTS601020S, RTS601021S, RTS601349S, RTS601352S, RTS601362S, RTS601368S, RTS601390S, RTS601505S, RTS601523S, RTS601527S, RTS602083S, RTS602095S, RTS602099S, RTS602119S, RTS602120S, RTS602195S, RTS602200S, RTS602231S, RTS602234S, RTS600488S, RTS600901S, RTS601110S, RTS601124S, RTS602522S, RTS600027S, RTS600039S, RTS600318S, RTS600335S, RTS600426S, RTS601024S, RTS601850S, RTS600947S, RTS600948S, RTS600991S, RTS600993S, RTS600995S, RTS601002S, RTS601052S, RTS601091S, RTS601129S, RTS601146S, RTS601233S, RTS601239S, RTS601354S, RTS601355S, RTS601358S, RTS601515S, RTS601517S, RTS601520S, RTS601522S, RTS601526S, RTS602080S, RTS602085S, RTS602121S, RTS602126S, RTS602135S, RTS602137S, RTS602192S, RTS602212S, RTS602230S, RTS602237S, RTS602426S, RTS602884S, RTS602946S, RTS602980S, RTS601139S, RTS602454S, RTS602531S, RTS600020S, RTS600561S, RTS601145S, RTS600496S, RTS600934S, RTS601082S, RTS602488S, RTS602718S, RTS603019S, RTS601351S, RTS600050S, RTS600056S, RTS600066S, RTS601435S, RTS601464S, RTS601602S, RTS601679S, RTS601680S, RTS601681S, RTS601780S, RTS601791S, RTS601796S, RTS601798S, RTS601822S, RTS601826S, RTS601870S, RTS601877S, RTS601894S, RTS602098S, RTS602140S, RTS602158S, RTS602194S, RTS602196S, RTS602199S, RTS602202S, RTS602209S, RTS602213S, RTS602215S, RTS602427S, RTS602430S, RTS602439S, RTS602442S, RTS602443S, RTS602449S, RTS602568S, RTS602686S, RTS602795S, RTS602829S, RTS602830S, RTS602835S, RTS602840S, RTS602869S, RTS602877S, RTS602915S, RTS602916S, RTS602920S, RTS602923S, RTS602926S, RTS602940S, RTS602958S, RTS602974S, RTS602989S, RTS602998S, RTS603007S, RTS603039S, RTS603064S, RTS603074S, RTS603088S, RTS603095S, RTS603102S, RTS603105S, RTS603109S, RTS603123S, RTS603124S, RTS603134S, RTS603141S, RTS603144S, RTS603147S, RTS603150S, RTS603160S, RTS603161S, RTS603162S, RTS603163S, RTS603164S, RTS603165S, RTS603166S, RTS603168S, RTS603169S, RTS603170S, RTS603171S, RTS603173S, RTS603174S, RTS603175S, RTS603176S, RTS603178S, RTS603179S, RTS603180S, RTS603181S, RTS603182S, RTS603183S, RTS603184S, RTS603187S, RTS603189S, RTS603191S, RTS603192S, RTS603193S, RTS603194S, RTS603195S, RTS603196S, RTS603197S, RTS603204S, RTS603205S, RTS603206S, RTS603207S, RTS603208S, RTS603209S, RTS603210S, RTS603211S, RTS603212S, RTS603213S, RTS603214S, RTS603215S, RTS603216S, RTS603220S, RTS603221S, RTS603222S, RTS603223S, RTS603224S, RTS603225S, RTS603226S, RTS603227S, RTS603228S, RTS603229S, RTS603230S, RTS603231S, RTS603232S, RTS603233S, RTS603234S, RTS603235S, RTS603236S, RTS603237S, RTS603239S, RTS603240S, RTS603241S, RTS603250S, RTS603253S, RTS603254S, RTS603256S, RTS601148S, RTS601149S, RTS601155S, RTS601220S, RTS601240S, RTS601671S, RTS601810S, RTS601885S, RTS602220S, RTS602558S, RTS602824S, RTS602825S, RTS602942S, RTS602949S, RTS603058S, RTS603135S, RTS603156S

510(k) numbers

not on file

PMA numbers

["P010031S674"]

Product code

NIK

Firm FEI

2182208

Firm city

Mounds View

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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