Medtronic Neuromodulation: Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)

Recall number

Z-0693-2008

Recalling firm

Medtronic Neuromodulation

Product

Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)

Status

Terminated

Initiated

2007-10-01

Posted

2008-02-05

Terminated

2012-05-03

Reason

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

Root cause

Packaging change control

Action

A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.

Quantity

1,427

Distribution

Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom

Lot, serial or model codes

NFD100921H, NFD100922H, NFD100924H, NFD100925H, NFD100926H, NFD100928H, NFD100930H, NFD100931H, NFD100932H, NFD100939H, NFD100940H, NFD100941H, NFD100943H, NFD100944H, NFD100945H, NFD100946H, NFD100947H, NFD100948H, NFD100949H, NFD100950H, NFD100951H, NFD100952H, NFD100960H, NFD100961H, NFD100963H, NFD100964H, NFD100965H, NFD100966H, NFD100967H, NFD100968H, NFD100969H, NFD100970H, NFD100971H, NFD100974H, NFD100978H, NFD100980H, NFD100982H, NFD100983H, NFD100985H, NFD100986H, NFD100996H, NFD100997H, NFD100998H, NFD100999H, NFD101000H, NFD101002H, NFD101003H, NFD101005H, NFD101006H, NFD101007H, NFD101008H, NFD101009H, NFD101010H, NFD101011H, NFD101012H, NFD101013H, NFD101014H, NFD101015H, NFD101017H, NFD101018H, NFD101020H, NFD101021H, NFD101023H, NFD101024H, NFD101025H, NFD101026H, NFD101027H, NFD101028H, NFD101030H, NFD101031H, NFD101033H, NFD101035H, NFD101036H, NFD101037H, NFD101038H, NFD101040H, NFD101041H, NFD101042H, NFD101043H, NFD101044H, NFD101045H, NFD101046H, NFD101047H, NFD101048H, NFD101049H, NFD101050H, NFD101051H, NFD101053H, NFD101055H, NFD101056H, NFD101057H, NFD101058H, NFD101060H, NFD101061H, NFD101062H, NFD101064H, NFD101066H, NFD101070H, NFD101073H, NFD101075H, NFD101076H, NFD101077H, NFD101078H, NFD101079H, NFD101080H, NFD101081H, NFD101082H, NFD101085H, NFD101087H, NFD101088H, NFD101089H, NFD101090H, NFD101092H, NFD101093H, NFD101094H, NFD101095H, NFD101096H, NFD101097H, NFD101098H, NFD101099H, NFD101100H, NFD101101H, NFD101102H, NFD101103H, NFD101104H, NFD101105H, NFD101106H, NFD101110H, NFD101132H, NFD101136H, NFD101140H, NFD101141H, NFD101146H, NFD101237H, NFD101243H, NFD101248H, NFD101249H, NFD621879S, NFD621880S, NFD621882S, NFD621883S, NFD621884S, NFD621885S, NFD621886S, NFD621887S, NFD621888S, NFD621889S, NFD621891S, NFD621892S, NFD621893S, NFD621895S, NFD621896S, NFD621897S, NFD621898S, NFD621900S, NFD621901S, NFD621902S, NFD621903S, NFD621904S, NFD621905S, NFD621906S, NFD621908S, NFD621910S, NFD621911S, NFD621912S, NFD621914S, NFD621915S, NFD621916S, NFD621917S, NFD621918S, NFD621919S, NFD621920S, NFD621921S, NFD621922S, NFD621923S, NFD621924S, NFD621925S, NFD621926S, NFD621927S, NFD621928S, NFD621929S, NFD621931S, NFD621932S, NFD621933S, NFD621934S, NFD621935S, NFD621936S, NFD621937S, NFD621938S, NFD621939S, NFD621940S, NFD621941S, NFD621943S, NFD621949S, NFD621951S, NFD621953S, NFD621958S, NFD621963S, NFD621964S, NFD621968S, NFD621979S, NFD621981S, NFD621982S, NFD621989S, NFD621991S, NFD621992S, NFD621995S, NFD622004S, NFD622005S, NFD622008S, NFD622011S, NFD622013S, NFD622014S, NFD622015S, NFD622016S, NFD622019S, NFD622020S, NFD622023S, NFD622024S, NFD622026S, NFD622027S, NFD622029S, NFD622030S, NFD622031S, NFD622033S, NFD622035S, NFD622037S, NFD622038S, NFD622039S, NFD622040S, NFD622041S, NFD622043S, NFD622046S, NFD622048S, NFD622049S, NFD622050S, NFD622051S, NFD622052S, NFD622053S, NFD622054S, NFD622055S, NFD622056S, NFD622057S, NFD622058S, NFD622059S, NFD622060S, NFD622061S, NFD622062S, NFD622063S, NFD622064S, NFD622065S, NFD622066S, NFD622067S, NFD622068S, NFD622069S, NFD622071S, NFD622073S, NFD622074S, NFD622075S, NFD622076S, NFD622077S, NFD622078S, NFD622079S, NFD622080S, NFD622081S, NFD622082S, NFD622083S, NFD622084S, NFD622085S, NFD622086S, NFD622090S, NFD622092S, NFD622093S, NFD622094S, NFD622095S, NFD622096S, NFD622098S, NFD622099S, NFD622101S, NFD622102S, NFD622103S, NFD622104S, NFD622105S, NFD622107S, NFD622108S, NFD622109S, NFD622110S, NFD622111S, NFD622112S, NFD622113S, NFD622114S, NFD622115S, NFD622116S, NFD622117S, NFD622118S, NFD622119S, NFD622120S, NFD622121S, NFD622122S, NFD622123S, NFD622125S, NFD622126S, NFD622127S, NFD622128S, NFD622129S, NFD622130S, NFD622131S, NFD622132S, NFD622133S, NFD622134S, NFD622135S, NFD622136S, NFD622137S, NFD622138S, NFD622139S, NFD622142S, NFD622143S, NFD622145S, NFD622147S, NFD622148S, NFD622149S, NFD622150S, NFD622151S, NFD622152S, NFD622153S, NFD622154S, NFD622156S, NFD622157S, NFD622159S, NFD622161S, NFD622162S, NFD622163S, NFD622164S, NFD622165S, NFD622166S, NFD622167S, NFD622168S, NFD622169S, NFD622171S, NFD622173S, NFD622174S, NFD622175S, NFD622176S, NFD622178S, NFD622180S, NFD622181S, NFD622182S, NFD622183S, NFD622184S, NFD622185S, NFD622186S, NFD622188S, NFD622189S, NFD622190S, NFD622191S, NFD622194S, NFD622195S, NFD622196S, NFD622197S, NFD622198S, NFD622199S, NFD622200S, NFD622201S, NFD622202S, NFD622203S, NFD622205S, NFD622206S, NFD622207S, NFD622208S, NFD622209S, NFD622211S, NFD622212S, NFD622213S, NFD622215S, NFD622216S, NFD622218S, NFD622221S, NFD622222S, NFD622223S, NFD622224S, NFD622226S, NFD622227S, NFD622228S, NFD622229S, NFD622230S, NFD622231S, NFD622232S, NFD622233S, NFD622234S, NFD622236S, NFD622237S, NFD622238S, NFD622239S, NFD622242S, NFD622243S, NFD622244S, NFD622245S, NFD622246S, NFD622247S, NFD622248S, NFD622249S, NFD622250S, NFD622251S, NFD622252S, NFD622253S, NFD622254S, NFD622255S, NFD622257S, NFD622258S, NFD622259S, NFD622260S, NFD622261S, NFD622262S, NFD622263S, NFD622264S, NFD622265S, NFD622266S, NFD622268S, NFD622269S, NFD622270S, NFD622271S, NFD622272S, NFD622273S, NFD622275S, NFD622276S, NFD622277S, NFD622278S, NFD622279S, NFD622280S, NFD622281S, NFD622282S, NFD622283S, NFD622284S, NFD622285S, NFD622286S, NFD622287S, NFD622288S, NFD622289S, NFD622290S, NFD622291S, NFD622292S, NFD622293S, NFD622294S, NFD622295S, NFD622296S, NFD622297S, NFD622298S, NFD622299S, NFD622300S, NFD622301S, NFD622302S, NFD622303S, NFD622304S, NFD622305S, NFD622306S, NFD622307S, NFD622308S, NFD622309S, NFD622310S, NFD622312S, NFD622313S, NFD622315S, NFD622316S, NFD622317S, NFD622318S, NFD622320S, NFD622321S, NFD622322S, NFD622323S, NFD622324S, NFD622325S, NFD622326S, NFD622327S, NFD622328S, NFD622329S, NFD622330S, NFD622331S, NFD622333S, NFD622334S, NFD622335S, NFD622337S, NFD622340S, NFD622342S, NFD622343S, NFD622344S, NFD622345S, NFD622346S, NFD622347S, NFD622348S, NFD622349S, NFD622351S, NFD622352S, NFD622353S, NFD622354S, NFD622355S, NFD622356S, NFD622357S, NFD622358S, NFD622359S, NFD622360S, NFD622361S, NFD622362S, NFD622363S, NFD622364S, NFD622365S, NFD622366S, NFD622370S, NFD622371S, NFD622372S, NFD622373S, NFD622374S, NFD622375S, NFD622376S, NFD622377S, NFD622378S, NFD622379S, NFD622380S, NFD622381S, NFD622382S, NFD622383S, NFD622384S, NFD622385S, NFD622386S, NFD622387S, NFD622388S, NFD622389S, NFD622390S, NFD622391S, NFD622392S, NFD622394S, NFD622396S, NFD622397S, NFD622398S, NFD622399S, NFD622400S, NFD622401S, NFD622402S, NFD622403S, NFD622404S, NFD622405S, NFD622406S, NFD622407S, NFD622408S, NFD622409S, NFD622410S, NFD622411S, NFD622412S, NFD622413S, NFD622414S, NFD622415S, NFD622416S, NFD622417S, NFD622418S, NFD622419S, NFD622420S, NFD622421S, NFD622423S, NFD622424S, NFD622425S, NFD622427S, NFD622428S, NFD622429S, NFD622430S, NFD622431S, NFD622432S, NFD622433S, NFD622434S, NFD622435S, NFD622436S, NFD622437S, NFD622438S, NFD622439S, NFD622440S, NFD622441S, NFD622442S, NFD622443S, NFD622444S, NFD622445S, NFD622446S, NFD622448S, NFD622449S, NFD622450S, NFD622451S, NFD622452S, NFD622453S, NFD622457S, NFD622457S, NFD622458S, NFD622459S, NFD622460S, NFD622462S, NFD622476S, NFD622484S, NFD622488S, NFD622491S, NFD622497S, NFD622498S, NFD622499S, NFD622500S, NFD622501S, NFD622502S, NFD622503S, NFD622504S, NFD622505S, NFD622506S, NFD622507S, NFD622508S, NFD622509S, NFD622510S, NFD622511S, NFD622513S, NFD622514S, NFD622515S, NFD622516S, NFD622517S, NFD622518S, NFD622520S, NFD622521S, NFD622523S, NFD622524S, NFD622525S, NFD622526S, NFD622527S, NFD622528S, NFD622529S, NFD622530S, NFD622531S, NFD622532S, NFD622533S, NFD622534S, NFD622535S, NFD622536S, NFD622537S, NFD622539S, NFD622540S, NFD622541S, NFD622542S, NFD622543S, NFD622544S, NFD622545S, NFD622546S, NFD622547S, NFD622548S, NFD622549S, NFD622550S, NFD622551S, NFD622555S, NFD622556S, NFD622557S, NFD622558S, NFD622559S, NFD622560S, NFD622562S, NFD622563S, NFD622564S, NFD622565S, NFD622566S, NFD622568S, NFD622569S, NFD622570S, NFD622571S, NFD622572S, NFD622573S, NFD622574S, NFD622575S, NFD622577S, NFD622578S, NFD622579S, NFD622580S, NFD622581S, NFD622583S, NFD622584S, NFD622586S, NFD622587S, NFD622588S, NFD622589S, NFD622590S, NFD622591S, NFD622592S, NFD622593S, NFD622594S, NFD622598S, NFD622599S, NFD622602S, NFD622604S, NFD622605S, NFD622606S, NFD622607S, NFD622608S, NFD622610S, NFD622613S, NFD622615S, NFD622616S, NFD622617S, NFD622619S, NFD622620S, NFD622621S, NFD622622S, NFD622624S, NFD622625S, NFD622626S, NFD622627S, NFD622632S, NFD622633S, NFD622634S, NFD622635S, NFD622636S, NFD622638S, NFD622640S, NFD622642S, NFD622643S, NFD622646S, NFD622654S, NFD622659S, NFD622661S, NFD622662S, NFD622663S, NFD622666S, NFD622680S, NFD622682S, NFD622684S, NFD622685S, NFD622686S, NFD622687S, NFD622688S, NFD622689S, NFD622690S, NFD622692S, NFD622693S, NFD622694S, NFD622695S, NFD622697S, NFD622699S, NFD622700S, NFD622701S, NFD622702S, NFD622706S, NFD622716S, NFD622719S, NFD622720S, NFD622721S, NFD622722S, NFD622723S, NFD622727S, NFD622728S, NFD622729S, NFD622732S, NFD622733S, NFD622734S, NFD622742S, NFD622745S, NFD622764S, NFD622782S, NFD622823S, NFD622825S, NFD622826S, NFD622831S, NFD622832S, NFD622839S, NFD622841S, NFD622842S, NFD622844S, NFD622846S, NFD622853S, NFD622855S, NFD622856S, NFD622858S, NFD622859S, NFD622861S, NFD622868S, NFD622871S, NFD622964S, NFD622972S, NFD622978S, NFD622986S, NFD622992S, NFD622994S, NFD622997S, NFD622998S, NFD623021S, NFD623022S, NFD623023S, NFD623038S, NFD623041S, NFD623044S, NFD623045S, NFD623046S, NFD623050S, NFD623053S, NFD623054S, NFD623056S, NFD623061S, NFD623062S, NFD623068S, NFD623081S, NFD623110S, NFD623112S, NFD623118S, NFD623566S, NFD627407S, NFD627418S, NFD627420S, NFD627424S, NFD627425S, NFD627426S, NFD627427S, NFD627428S, NFD627429S, NFD627430S, NFD627431S, NFD627432S, NFD627433S, NFD627435S, NFD627436S, NFD627437S, NFD627439S, NFD627440S, NFD627441S, NFD627442S, NFD627443S, NFD627444S, NFD627445S, NFD627446S, NFD627447S, NFD627448S, NFD627450S, NFD627451S, NFD627452S, NFD627453S, NFD627454S, NFD627455S, NFD627457S, NFD627458S, NFD627459S, NFD627460S, NFD627462S, NFD627463S, NFD627464S, NFD627465S, NFD627466S, NFD627467S, NFD627468S, NFD627469S, NFD627470S, NFD627471S, NFD627472S, NFD627473S, NFD627474S, NFD627475S, NFD627476S, NFD627477S, NFD627478S, NFD627479S, NFD627480S, NFD627481S, NFD627482S, NFD627487S, NFD627491S, NFD627496S, NFD627497S, NFD627498S, NFD627502S, NFD627505S, NFD627507S, NFD627511S, NFD627512S, NFD627516S, NFD627525S, NFD627529S, NFD627532S, NFD627559S, NFD627564S, NFD627565S, NFD627566S, NFD627567S, NFD627568S, NFD627571S, NFD627572S, NFD627573S, NFD627574S, NFD627575S, NFD627576S, NFD627577S, NFD627578S, NFD627579S, NFD627581S, NFD627582S, NFD627583S, NFD627584S, NFD627585S, NFD627586S, NFD627587S, NFD627588S, NFD627589S, NFD627590S, NFD627591S, NFD627592S, NFD627593S, NFD627594S, NFD627595S, NFD627596S, NFD627597S, NFD627598S, NFD627599S, NFD627600S, NFD627601S, NFD627602S, NFD627603S, NFD627604S, NFD627605S, NFD627606S, NFD627607S, NFD627608S, NFD627609S, NFD627610S, NFD627611S, NFD627612S, NFD627614S, NFD627615S, NFD627616S, NFD627617S, NFD627618S, NFD627619S, NFD627620S, NFD627621S, NFD627622S, NFD627624S, NFD627625S, NFD627626S, NFD627627S, NFD627628S, NFD627629S, NFD627630S, NFD627631S, NFD627632S, NFD627633S, NFD627634S, NFD627635S, NFD627636S, NFD627637S, NFD627638S, NFD627639S, NFD627640S, NFD627641S, NFD627642S, NFD627643S, NFD627644S, NFD627645S, NFD627646S, NFD627647S, NFD627648S, NFD627650S, NFD627651S, NFD627652S, NFD627653S, NFD627654S, NFD627655S, NFD627656S, NFD627657S, NFD627658S, NFD627659S, NFD627660S, NFD627661S, NFD627662S, NFD627663S, NFD627664S, NFD627665S, NFD627666S, NFD627667S, NFD627668S, NFD627669S, NFD627670S, NFD627671S, NFD627672S, NFD627673S, NFD627674S, NFD627675S, NFD627676S, NFD627677S, NFD627678S, NFD627679S, NFD627680S, NFD627681S, NFD627682S, NFD627683S, NFD627684S, NFD627685S, NFD627686S, NFD627687S, NFD627688S, NFD627689S, NFD627690S, NFD627691S, NFD627692S, NFD627693S, NFD627694S, NFD627695S, NFD627696S, NFD627697S, NFD627698S.NFD627699S, NFD627700S, NFD627701S, NFD627702S, NFD627703S, NFD627704S, NFD627707S, NFD627708S, NFD627709S, NFD627710S, NFD627711S, NFD627712S, NFD627713S, NFD627714S, NFD627715S, NFD627716S, NFD627717S, NFD627718S, NFD627719S, NFD627720S, NFD627721S, NFD627722S, NFD627723S, NFD627724S, NFD627725S, NFD627726S, NFD627727S, NFD627728S, NFD627729S, NFD627730S, NFD627731S, NFD627732S, NFD627733S, NFD627734S, NFD627735S, NFD627736S, NFD627737S, NFD627738S, NFD627739S, NFD627740S, NFD627741S, NFD627742S, NFD627743S, NFD627744S, NFD627745S, NFD627746S, NFD627747S, NFD627748S, NFD627749S, NFD627750S, NFD627751S, NFD627752S, NFD627753S, NFD627754S, NFD627755S, NFD627756S, NFD627757S, NFD627758S, NFD627759S, NFD627760S, NFD627761S, NFD627762S, NFD627763S, NFD627764S, NFD627765S, NFD627766S, NFD627767S, NFD627768S, NFD627769S, NFD627770S, NFD627771S, NFD627773S, NFD627774S, NFD627775S, NFD627776S, NFD627777S, NFD627778S, NFD627779S, NFD627780S, NFD627781S, NFD627782S, NFD627783S, NFD627784S, NFD627785S, NFD627786S, NFD627787S, NFD627788S, NFD627789S, NFD627790S, NFD627791S, NFD627793S, NFD627794S, NFD627795S, NFD627796S, NFD627797S, NFD627798S, NFD627799S, NFD627800S, NFD627801S, NFD627802S, NFD627803S, NFD627804S, NFD627805S, NFD627806S, NFD627807S, NFD627808S, NFD627809S, NFD627810S, NFD627811S, NFD627812S, NFD627813S, NFD627814S, NFD627815S, NFD627816S, NFD627817S, NFD627818S, NFD627819S, NFD627820S, NFD627821S, NFD627822S, NFD627823S, NFD627824S, NFD627825S, NFD627826S, NFD627827S, NFD627828S, NFD627829S, NFD627830S, NFD627831S, NFD627832S, NFD627833S, NFD627835S, NFD627836S, NFD627837S, NFD627838S, NFD627839S, NFD627840S, NFD627841S, NFD627842S, NFD627843S, NFD627845S, NFD627846S, NFD627847S, NFD627848S, NFD627850S, NFD627851S, NFD627852S, NFD627853S, NFD627854S, NFD627855S, NFD627856S, NFD627857S, NFD627858S, NFD627859S, NFD627860S, NFD627861S, NFD627862S, NFD627863S, NFD627864S, NFD627865S, NFD627866S, NFD627867S, NFD627868S, NFD627869S, NFD627870S, NFD627871S, NFD627872S, NFD627873S, NFD627874S, NFD627875S, NFD627876S, NFD627877S, NFD627878S, NFD627879S, NFD627880S, NFD627881S, NFD627882S, NFD627883S, NFD627884S, NFD627885S, NFD627886S, NFD627887S, NFD627888S, NFD627889S, NFD627890S, NFD627891S, NFD627892S, NFD627893S, NFD627894S, NFD627895S, NFD627896S, NFD627897S, NFD627898S, NFD627899S, NFD627900S, NFD627901S, NFD627902S, NFD627903S, NFD627904S, NFD627905S, NFD627906S, NFD627907S, NFD627908S, NFD627909S, NFD627910S, NFD627911S, NFD627912S, NFD627913S, NFD627914S, NFD627915S, NFD627916S, NFD627917S, NFD627918S, NFD627919S, NFD627920S, NFD627921S, NFD627922S, NFD627923S, NFD627924S, NFD627925S, NFD627926S, NFD627927S, NFD627928S, NFD627929S, NFD627930S, NFD627931S, NFD627932S, NFD627933S, NFD627934S, NFD627935S, NFD627936S, NFD627937S, NFD627938S, NFD627939S, NFD627940S, NFD627941S, NFD627942S, NFD627943S, NFD627944S, NFD627945S, NFD627946S, NFD627947S, NFD627948S, NFD627949S, NFD627950S, NFD627951S, NFD627952S, NFD627953S, NFD627954S, NFD627955S, NFD627956S, NFD627957S, NFD627958S, NFD627959S, NFD627960S, NFD627962S, NFD627965S, NFD627966S, NFD627968S, NFD627969S, NFD627970S, NFD627971S, NFD627973S, NFD627974S, NFD627975S, NFD627976S, NFD627977S, NFD627979S, NFD627981S, NFD627982S, NFD627983S, NFD627984S, NFD627985S, NFD627986S, NFD627987S, NFD627988S, NFD627989S, NFD627990S, NFD627993S, NFD627994S, NFD627996S, NFD627997S, NFD627998S, NFD628000S, NFD628001S, NFD628002S, NFD628003S, NFD628004S, NFD628005S, NFD628006S, NFD628007S, NFD628008S, NFD628009S, NFD628010S, NFD628011S, NFD628012S, NFD628014S, NFD628015S, NFD628016S, NFD628017S, NFD628019S, NFD628021S, NFD628022S, NFD628023S, NFD628024S, NFD628027S, NFD628028S, NFD628030S, NFD628031S, NFD628036S, NFD628039S, NFD628042S, NFD628043S, NFD628044S, NFD628046S, NFD628053S, NFD628055S, NFD628056S, NFD628057S, NFD628059S, NFD628061S, NFD628063S, NFD628074S, NFD628076S, NFD628079S, NFD628080S, NFD628082S, NFD628085S, NFD628086S, NFD628089S, NFD628092S, NFD628094S, NFD628102S, NFD628103S, NFD628109S, NFD628110S, NFD628114S, NFD628116S, NFD628120S, NFD628122S, NFD628125S, NFD628128S, NFD628129S, NFD628130S, NFD628131S, NFD628133S, NFD628134S, NFD628148S, NFD628153S, NFD628188S, NFD628191S, NFD628192S, NFD628195S, NFD628196S, NFD628197S, NFD628205S, NFD628207S, NFD628208S, NFD628210S, NFD628275S, NFD628283S, NFD628284S, NFD628286S, NFD628292S, NFD628293S, NFD628296S, NFD628298S, NFD628299S, NFD628300S, NFD628301S, NFD628304S, NFD628305S, NFD628306S, NFD628307S, NFD628308S, NFD628311S, NFD628312S, NFD628314S, NFD628315S, NFD628316S, NFD628320S, NFD628322S, NFD628323S, NFD628324S, NFD628325S, NFD628326S, NFD628327S, NFD628328S, NFD628329S, NFD628330S, NFD628331S, NFD628332S, NFD628333S, NFD628334S, NFD628335S, NFD628336S, NFD628337S, NFD628338S, NFD628339S, NFD628340S, NFD628342S, NFD628343S, NFD628344S, NFD628346S, NFD628347S, NFD628348S, NFD628349S, NFD628350S, NFD628351S, NFD628353S, NFD628354S, NFD628355S, NFD628357S, NFD628359S, NFD628362S, NFD628364S, NFD628365S, NFD628366S, NFD628367S, NFD628370S, NFD628371S, NFD628377S, NFD628378S, NFD628379S, NFD628383S, NFD628385S, and NFD628386S

510(k) numbers

not on file

PMA numbers

not on file

Product code

MHY

Firm FEI

2182207

Firm city

Minneapolis

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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