Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators

Recall number

Z-1783-2023

Recalling firm

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

Product

CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; 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

1878 units

Distribution

US Nationwide - Worldwide Distribution

Lot, serial or model codes

GTIN 00763000178185, Lot Serial Numbers: RTL600234S, RTL600470S, RTL601046S, RTL601412S, RTL601722S, RTL601669S, RTL601698S, RTL600323S, RTL600660S, RTL600661S, RTL601185S, RTL601206S, RTL601213S, RTL601406S, RTL601445S, RTL601446S, RTL600649S, RTL600650S, RTL601428S, RTL601017S, RTL600219S, RTL601076S, RTL601544S, RTL602514S, RTL600684S, RTL601477S, RTL601865S, RTL600638S, RTL600639S, RTL600640S, RTL600641S, RTL600642S, RTL600643S, RTL601151S, RTL601154S, RTL601156S, RTL601160S, RTL601161S, RTL601162S, RTL601163S, RTL601164S, RTL601165S, RTL601167S, RTL601170S, RTL600209S, RTL600835S, RTL600997S, RTL600519S, RTL601459S, RTL601689S, RTL600978S, RTL601540S, RTL601880S, RTL600522S, RTL601510S, RTL600949S, RTL601624S, RTL601372S, RTL600810S, RTL600266S, RTL600281S, RTL600528S, RTL600596S, RTL600654S, RTL600777S, RTL600813S, RTL600841S, RTL600846S, RTL601563S, RTL601021S, RTL601208S, RTL600243S, RTL600244S, RTL600245S, RTL600533S, RTL601085S, RTL601148S, RTL601373S, RTL601231S, RTL601864S, 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RTL602066S, RTL602067S, RTL602068S, RTL602069S, RTL602070S, RTL602071S, RTL602072S, RTL602073S, RTL602074S, RTL602075S, RTL602076S, RTL602077S, RTL602078S, RTL602079S, RTL602080S, RTL602081S, RTL602082S, RTL602083S, RTL602084S, RTL602085S, RTL602087S, RTL602089S, RTL602094S, RTL602097S, RTL602098S, RTL602141S, RTL602142S, RTL602143S, RTL602149S, RTL602150S, RTL602159S, RTL602161S, RTL602162S, RTL602165S, RTL602166S, RTL602168S, RTL602194S, RTL602195S, RTL602196S, RTL602197S, RTL602199S, RTL602200S, RTL602201S, RTL602202S, RTL602204S, RTL602205S, RTL602206S, RTL602207S, RTL602208S, RTL602209S, RTL602212S, RTL602213S, RTL602214S, RTL602215S, RTL602216S, RTL602217S, RTL602220S, RTL602222S, RTL602223S, RTL602224S, RTL602225S, RTL602226S, RTL602227S, RTL602228S, RTL602229S, RTL602231S, RTL602237S, RTL602248S, RTL602264S, RTL602265S, RTL602267S, RTL602268S, RTL602269S, RTL602272S, RTL602273S, RTL602274S, RTL602275S, RTL602276S, RTL602277S, RTL602278S, RTL602279S, RTL602282S, RTL602283S, RTL602284S, RTL602288S, RTL602289S, RTL602293S, RTL602294S, RTL602297S, RTL602298S, RTL602299S, RTL602301S, RTL602302S, RTL602303S, RTL602305S, RTL602308S, RTL602309S, RTL602311S, RTL602313S, RTL602316S, RTL602317S, RTL602319S, RTL602322S, RTL602323S, RTL602324S, RTL602327S, RTL602329S, RTL602333S, RTL602334S, RTL602337S, RTL602340S, RTL602341S, RTL602343S, RTL602344S, RTL602348S, RTL602349S, RTL602352S, RTL602357S, RTL602362S, RTL602363S, RTL602366S, RTL602367S, RTL602383S, RTL602387S, RTL602388S, RTL602391S, RTL602398S, RTL602400S, RTL602401S, RTL602402S, RTL602411S, RTL602412S, RTL602413S, RTL602416S, RTL602417S, RTL602422S, RTL602424S, RTL602426S, RTL602427S, RTL602430S, RTL602434S, RTL602436S, RTL602463S, RTL602481S, RTL602492S, RTL602497S, RTL602499S, RTL602517S, RTL602519S, RTL602520S, RTL602529S, RTL602527S, RTL602528S, RTL600603S, RTL601397S, RTL601718S, RTL600511S, RTL601981S, RTL602365S, RTL601396S, RTL600175S, RTL600613S, RTL600626S, RTL600701S, RTL601863S, RTL600388S, RTL601495S, RTL601702S, RTL601703S, RTL601713S, RTL601962S, RTL602304S, RTL600966S, RTL600314S, RTL600379S, RTL600380S, RTL600383S, RTL601430S, RTL601803S, RTL601780S, RTL600561S, RTL600948S, RTL601050S, RTL600147S, RTL600820S, RTL601369S, RTL601391S, RTL601408S, RTL601452S, RTL601454S, RTL600334S, RTL601303S, RTL601604S, RTL600710S, RTL600172S, RTL600276S, RTL600300S, RTL600419S, RTL600420S, RTL600422S, RTL601314S, RTL601380S, RTL601486S, RTL601941S, RTL601959S, RTL601135S, RTL601421S, RTL600598S, RTL600647S, RTL601603S, RTL601636S, RTL601838S, RTL601861S, RTL601925S, RTL600849S, RTL601182S, RTL601200S, RTL601411S, RTL600481S, RTL600779S, RTL601311S, RTL601815S, RTL601597S, RTL600372S, RTL600205S, RTL600337S, RTL600531S, RTL601211S, RTL601705S, RTL601776S, RTL601790S, RTL601844S, RTL601870S, RTL601344S, RTL600955S, RTL601643S, RTL601648S, RTL601683S, RTL601830S, RTL601876S, RTL601308S, RTL600412S, RTL600766S, RTL601779S, RTL600667S, RTL600745S, RTL601573S, RTL601420S, RTL600432S, RTL600597S, RTL601426S, RTL601782S, RTL601935S, RTL601936S, RTL600765S, RTL601177S, RTL601672S, RTL601949S, RTL602090S, RTL600402S, RTL601010S, RTL601086S, RTL601791S, RTL601794S, RTL601795S, RTL601796S, RTL601848S, RTL601290S, RTL600594S, RTL601564S, RTL601329S, RTL600173S, RTL601611S, RTL601656S, RTL601820S, RTL600267S, RTL600287S, RTL600271S, RTL600714S, RTL601138S, RTL601197S, RTL601318S, RTL601395S, RTL601111S, RTL600768S, RTL600769S, RTL601230S, RTL601052S, RTL600410S, RTL600692S, RTL600324S, RTL600538S, RTL601313S, RTL601798S, RTL600457S, RTL600988S, RTL600989S, RTL601829S, RTL600159S, RTL600496S, RTL601466S, RTL600301S, RTL600510S, RTL600562S, RTL601362S, RTL601508S, RTL601682S, RTL601707S, RTL601730S, RTL600389S, RTL601602S, RTL600645S, RTL600515S, RTL600578S, RTL600252S, RTL600370S, RTL601330S, RTL601375S, RTL601376S, RTL601432S, RTL601527S, RTL601559S, RTL601565S, RTL600180S, RTL600265S, RTL600280S, RTL600286S, RTL600513S, RTL600572S, RTL600580S, RTL601214S, RTL601240S, RTL601433S, RTL600386S, RTL600387S, RTL600763S, RTL601158S, RTL600251S, RTL600656S, RTL601550S, RTL600307S, RTL600853S, RTL600943S, RTL600985S, RTL601106S, RTL601108S, RTL601216S, RTL601348S, RTL601535S, RTL601558S, RTL601623S, RTL601818S, RTL600657S, RTL601001S, RTL601098S, RTL600848S, RTL600674S, RTL601526S, RTL601867S, RTL600535S, RTL600469S, RTL601498S, RTL601835S, RTL600737S, RTL601840S, RTL601923S, RTL600157S, RTL600724S, RTL600131S, RTL601546S, RTL601547S, RTL601897S, RTL601910S, RTL600474S, RTL600605S, RTL600196S, RTL600260S, RTL600680S, RTL601882S, RTL601065S, RTL601594S, RTL600518S, RTL601502S, RTL600331S, RTL600586S, RTL601008S, RTL601218S, RTL601296S, RTL601388S, RTL601453S, RTL601552S, RTL601569S, RTL601915S, RTL601940S, RTL601982S, RTL601987S, RTL601993S, RTL600310S, RTL601221S, RTL602368S, RTL602369S, RTL602370S, RTL602371S, RTL602373S, RTL602374S, RTL602375S, RTL602376S, RTL602377S, RTL602378S, RTL602379S, RTL602380S, RTL602381S, RTL602382S, RTL600290S, RTL600132S, RTL600133S, RTL600449S, RTL600530S, RTL600837S, RTL601014S, RTL601507S, RTL601720S, RTL601812S, RTL601853S, RTL600681S, RTL600459S, RTL601810S, RTL601846S, RTL601907S, RTL601424S, RTL601591S, RTL600197S, RTL600224S, RTL600351S, RTL601359S, RTL601401S, RTL600284S, RTL600619S, RTL600632S, RTL600758S, RTL601849S, RTL601946S, RTL601487S, RTL600294S, RTL600305S, RTL600417S, RTL601549S, RTL600375S, RTL600636S, RTL600395S, RTL600537S, RTL600009S, RTL600137S, RTL600198S, RTL600199S, RTL600567S, RTL600570S, RTL600577S, RTL600665S, RTL600730S, RTL601039S, RTL601048S, RTL601653S, RTL602538S, RTL600357S, RTL601335S, RTL601860S, RTL600627S, RTL601904S, RTL600355S, RTL601472S, RTL601721S, RTL600268S, RTL600514S, RTL600302S, RTL600565S, RTL601019S, RTL601088S, RTL601557S, RTL601612S, RTL600628S, RTL601252S, RTL601094S, RTL601191S, RTL600235S, RTL600130S, RTL600489S, RTL600707S, RTL600718S, RTL600838S, RTL601115S, RTL601331S, RTL601332S, RTL600213S, RTL600427S, RTL600697S, RTL601234S, RTL600371S, RTL600702S, RTL600951S, RTL600283S, RTL601893S, RTL600939S, RTL601146S, RTL600399S, RTL600999S, RTL601000S, RTL601107S, RTL601280S, RTL601732S, RTL601733S, RTL601890S, RTL601892S, RTL601912S, RTL602110S, RTL602239S, RTL602250S, RTL602251S, RTL602254S, RTL600221S, RTL601090S, RTL600155S, RTL600471S, RTL600525S, RTL601366S, RTL601727S, RTL601024S, RTL602544S, RTL600327S, RTL600328S, RTL600475S, RTL600666S, RTL600935S, RTL601034S, RTL601036S, RTL601056S, RTL601227S, RTL601229S, RTL601929S, RTL601930S, RTL601958S, RTL602116S, RTL601305S, RTL601233S, RTL601537S, RTL601538S, RTL600933S, RTL601926S, RTL601587S, RTL601149S, RTL601150S, RTL601675S, RTL601341S, RTL600589S, RTL600181S, RTL600237S, RTL600365S, RTL601862S, RTL600494S, RTL600166S, RTL600772S, RTL601903S, RTL600366S, RTL601009S, RTL601654S, RTL601072S, RTL600406S, RTL601855S, RTL601665S, RTL600112S, RTL600120S, RTL600123S, RTL600129S, RTL600160S, RTL600762S, RTL601246S, RTL601339S, RTL601381S, RTL601382S, RTL601493S, RTL601556S, RTL600232S, RTL601679S, RTL600437S, RTL601614S, RTL601114S, RTL601873S, RTL600261S, RTL600279S, RTL601173S, RTL600438S, RTL600439S, RTL601389S, RTL601738S, RTL601740S, RTL601404S, RTL600378S, RTL601431S, RTL600291S, RTL600321S, RTL600818S, RTL600845S, RTL601215S, RTL601217S, RTL601241S, RTL601251S, RTL601394S, RTL601583S, RTL601418S, RTL601323S, RTL601422S, RTL600749S, RTL601066S, RTL601100S, RTL600274S, RTL601425S, RTL600153S, RTL600184S, RTL600242S, RTL600391S, RTL600582S, RTL601112S, RTL601443S, RTL600295S, RTL600312S, RTL600476S, RTL600722S, RTL600767S, RTL601002S, RTL601058S, RTL601155S, RTL601228S, RTL601413S, RTL601684S, RTL600962S, RTL600254S, RTL601501S, RTL600253S, RTL600352S, RTL600304S, RTL600306S, RTL600363S, RTL600473S, RTL601832S, RTL600336S, RTL600341S, RTL600344S, RTL600381S, RTL600671S, RTL600703S, RTL600958S, RTL601104S, RTL601276S, RTL601283S, RTL601309S, RTL601346S, RTL601347S, RTL601444S, RTL601489S, RTL601663S, RTL601766S, RTL601788S, RTL601887S, RTL601899S, RTL601652S, RTL600397S, RTL601337S, RTL601542S, RTL601275S, RTL601450S, RTL600179S, RTL600083S, RTL600385S, RTL600743S, RTL601627S, RTL601826S, RTL601978S, RTL601979S, RTL601133S, RTL601533S, RTL600404S, RTL600634S, RTL600140S, RTL600293S, RTL600803S, RTL602113S, RTL600429S, RTL600814S, RTL601061S, RTL601212S, RTL601555S, RTL601833S, RTL602063S, RTL600850S, RTL600361S, RTL600662S, RTL600778S, RTL600804S, RTL601125S, RTL600756S, RTL600786S, RTL600787S, RTL600788S, RTL600791S, RTL600792S, RTL601099S, RTL601121S, RTL601244S, RTL601576S, RTL601579S, RTL601986S, RTL601990S, RTL602011S, RTL602013S, RTL602135S, RTL602136S, RTL602137S, RTL602140S, RTL602151S, RTL602152S, RTL602153S, RTL602173S, RTL602256S, RTL602257S, RTL602258S, RTL602259S, RTL602260S, RTL602261S, RTL602262S, RTL602263S, RTL600085S, RTL600541S, RTL600576S, RTL600967S, RTL601122S, RTL601393S, RTL601442S, RTL601554S, RTL601618S, RTL601639S, RTL601674S, RTL601363S, RTL601629S, RTL601678S, RTL601691S, RTL601704S, RTL601765S, RTL601767S, RTL601769S, RTL601770S, RTL601771S, RTL601774S, RTL601834S, RTL601913S, RTL601312S, RTL600610S, RTL600746S, RTL600843S, RTL600847S, RTL601063S, RTL601081S, RTL601137S, RTL602092S, RTL601026S, RTL600801S, RTL600802S, RTL600979S, RTL600983S, RTL601931S, RTL602106S, RTL602107S, RTL602123S, RTL602124S, RTL602244S, RTL601334S, RTL600621S, RTL600622S, RTL600623S, RTL600624S, RTL600625S, RTL600509S, RTL601528S, RTL600105S, RTL600764S, RTL600139S, RTL601924S, RTL601139S, RTL600330S, RTL600560S, RTL601172S, RTL600832S, RTL600150S, RTL600604S, RTL600781S, RTL601356S, RTL601695S, RTL601699S, RTL601726S, RTL601785S, RTL601816S, RTL602100S, RTL602104S, RTL602105S, RTL601480S, RTL601440S; GTIN 00763000178208, Lot Serial numbers: RTL600040S, RTL602020S, RTL602180S, RTL602548S, RTL600014S, RTL601004S, RTL602177S, RTL602186S, RTL602171S, RTL601756S, RTL601983S, RTL601499S, RTL601018S, RTL602003S, RTL602008S, RTL602441S, RTL600036S, RTL600984S, RTL601504S, RTL601578S, RTL600037S, RTL601447S, RTL601645S, RTL601757S, RTL602193S, RTL602004S, RTL602191S, RTL602443S, RTL600022S, RTL600032S, RTL601522S, RTL601539S, RTL600071S, RTL601505S, RTL602429S, RTL601744S, RTL601966S, RTL600074S, RTL600076S, RTL602109S, RTL602360S, RTL602396S, RTL602435S, RTL602460S, RTL600023S, RTL601637S, RTL602043S, RTL602535S, RTL601742S, RTL600007S, RTL601043S, RTL602187S, RTL601047S, RTL600970S, RTL600044S, RTL601633S, RTL600038S, RTL600042S, RTL600043S, RTL600050S, RTL600069S, RTL600072S, RTL601037S, RTL601285S, RTL601745S, RTL602179S, RTL600030S, RTL600010S, RTL601518S, RTL601625S, RTL601746S, RTL600008S, RTL600027S, RTL601997S, RTL601998S, RTL602169S, RTL602192S, RTL602458S, RTL602474S, RTL602183S, RTL601581S, RTL600993S, RTL600103S, RTL600099S, RTL600102S, RTL600098S, RTL601992S, RTL600086S, RTL600096S, RTL600097S, RTL600100S, RTL601750S, RTL601751S, RTL601759S, RTL601991S, RTL602002S, RTL602010S, RTL602019S, RTL602009S, RTL602026S, RTL601028S, RTL602001S, RTL602024S, RTL601717S, RTL600079S, RTL601752S, RTL601515S, RTL602175S, RTL601525S, RTL602184S, RTL600973S, RTL602190S, RTL600005S, RTL600017S, RTL601984S, RTL601985S, RTL601988S, RTL601989S, RTL601995S, RTL601996S, RTL601999S, RTL602000S, RTL602147S, RTL602154S, RTL602164S, RTL602459S, RTL602471S, RTL602473S, RTL602476S, RTL602477S, RTL601758S, RTL602016S, RTL602088S, RTL602158S, RTL602457S, RTL601511S, RTL602015S, RTL601725S, RTL602062S, RTL602174S, RTL602005S, RTL602006S, RTL602007S, RTL602111S, RTL602120S, RTL602127S, RTL602138S, RTL602144S, RTL602185S, RTL602445S, RTL602466S, RTL602467S, RTL602472S, RTL602546S, RTL602547S, RTL602649S, RTL602772S, RTL602788S, RTL602796S, RTL602797S, RTL602811S, RTL602819S, RTL602805S

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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