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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic KAPPA 600/700/900 Series Implantable Pulse Generators (IPGs)

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  Class 1 Device Recall Medtronic KAPPA 600/700/900 Series Implantable Pulse Generators (IPGs) see related information
Date Initiated by Firm May 18, 2009
Date Posted June 11, 2009
Recall Status1 Terminated 3 on March 28, 2012
Recall Number Z-1513-2009
Recall Event ID 52076
PMA Number P980035S031 
Product Classification Implantable Permanent Pulse-Generator - Product Code NVZ
Product Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.
Code Information Model KD701, serial numbers: PHK110034H, PHK110047H, PHK110050H, PHK110055H, PHK110059H, PHK110060H, PHK110063H, PHK623794S, PHK624053S, PHK624054S, PHK624055S, PHK624057S, PHK624058S, PHK624059S, PHK624060S, PHK624061S, PHK624062S, PHK624063S, PHK624064S, PHK624065S, PHK624067S, PHK624068S, PHK624069S, PHK624070S, PHK624071S, PHK624076S, PHK624077S, PHK624078S, PHK624079S, PHK624080S, PHK624081S, PHK624082S, PHK624083S, PHK624084S, PHK624085S, PHK624086S, PHK624087S, PHK624088S, PHK624090S, PHK624091S, PHK624092S, PHK624093S, PHK624094S, PHK624095S, PHK624096S, PHK624098S, PHK624099S, PHK624100S, PHK624101S, PHK624102S, PHK624103S, PHK624106S, PHK624107S, PHK624108S, PHK624109S, PHK624110S, PHK624111S, PHK624112S, PHK624113S, PHK624114S, PHK624115S, PHK624116S, PHK624117S, PHK624118S, PHK624119S, PHK624120S, PHK624122S, PHK624123S, PHK624124S, PHK624125S, PHK624126S, PHK624127S, PHK624129S, PHK624130S, PHK624131S, PHK624132S, PHK624133S, PHK624134S, PHK624135S, PHK624136S, PHK624137S, PHK624138S, PHK624139S, PHK624140S, PHK624141S, PHK624142S, PHK624143S, PHK624145S, PHK624146S, PHK624147S, PHK624148S, PHK624149S, PHK624150S, PHK624151S, PHK624152S, PHK624153S, PHK624154S, PHK624156S, PHK624157S, PHK624158S, PHK624160S, PHK624161S, PHK624163S, PHK624164S, PHK624165S, PHK624166S, PHK624167S, PHK624168S, PHK624169S, PHK624170S, PHK624171S, PHK624172S, PHK624173S, PHK624174S, PHK624175S, PHK624176S, PHK624177S, PHK624178S, PHK624179S, PHK624180S, PHK624181S, PHK624182S, PHK624183S, PHK624184S, PHK624185S, PHK624186S, PHK624187S, PHK624188S, PHK624189S, PHK624190S, PHK624191S, PHK624192S, PHK624193S, PHK624194S, PHK624195S, PHK624196S, PHK624197S, PHK624198S, PHK624199S, PHK624200S, PHK624201S, PHK624202S, PHK624203S, PHK624205S, PHK624206S, PHK624207S, PHK624208S, PHK624209S, PHK624210S, PHK624211S, PHK624212S, PHK624213S, PHK624214S, PHK624215S, PHK624216S, PHK624217S, PHK624218S, PHK624219S, PHK624220S, PHK624221S, PHK624222S, PHK624223S, PHK624224S, PHK624225S, PHK624226S, PHK624227S, PHK624228S, PHK624230S, PHK624231S, PHK624232S, PHK624233S, PHK624234S, PHK624235S, PHK624236S, PHK624237S, PHK624238S, PHK624240S, PHK624242S, PHK624243S, PHK624244S, PHK624245S, PHK624246S, PHK624247S, PHK624248S, PHK624249S, PHK624250S, PHK624251S, PHK624252S, PHK624253S, PHK624254S, PHK624255S, PHK624256S, PHK624257S, PHK624258S, PHK624260S, PHK624261S, PHK624262S, PHK624263S, PHK624264S, PHK624265S, PHK624266S, PHK624267S, PHK624269S, PHK624270S, PHK624271S, PHK624272S, PHK624273S, PHK624274S, PHK624276S, PHK624277S, PHK624278S, PHK624279S, PHK624280S, PHK624281S, PHK624282S, PHK624283S, PHK624284S, PHK624285S, PHK624286S, PHK624287S, PHK624288S, PHK624289S, PHK624290S, PHK624291S, PHK624292S, PHK624293S, PHK624294S, PHK624295S, PHK624296S, PHK624297S, PHK624298S, PHK624299S, PHK624300S, PHK624301S, PHK624302S, PHK624303S, PHK624304S, PHK624305S, PHK624306S, PHK624307S, PHK624308S, PHK624309S, PHK624310S, PHK624311S, PHK624312S, PHK624313S, PHK624315S, PHK624316S, PHK624317S, PHK624318S, PHK624319S, PHK624320S, PHK624321S, PHK624322S, PHK624323S, PHK624324S, PHK624325S, PHK624326S, PHK624327S, PHK624328S, PHK624329S, PHK624330S, PHK624331S, PHK624332S, PHK624333S, PHK624334S, PHK624335S, PHK624336S, PHK624337S, PHK624339S, PHK624340S, PHK624341S, PHK624342S, PHK624344S, PHK624345S, PHK624346S, PHK624347S, PHK624349S, PHK624350S, PHK624351S, PHK624352S, PHK624353S, PHK624354S, PHK624355S, PHK624356S, PHK624357S, PHK624358S, PHK624359S, PHK624360S, PHK624361S, PHK624362S, PHK624363S, PHK624364S, PHK624365S, PHK624366S, PHK624367S, PHK624368S, PHK624369S, PHK624370S, PHK624371S, PHK624372S, PHK624373S, PHK624374S, PHK624375S, PHK624376S, PHK624377S, PHK624378S, PHK624379S, PHK624380S, PHK624381S, PHK624383S, PHK624384S, PHK624385S, PHK624386S, PHK624387S, PHK624388S, PHK624389S, PHK624390S, PHK624391S, PHK624393S, PHK624395S, PHK624397S, PHK624398S, PHK624399S, PHK624401S, PHK624402S, PHK624403S, PHK624406S, PHK624407S, PHK624408S, PHK624409S, PHK624410S, PHK624411S, PHK624412S, PHK624413S, PHK624414S, PHK624415S, PHK624416S, PHK624417S, PHK624419S, PHK624420S, PHK624421S, PHK624422S, PHK624423S, PHK624424S, PHK624425S, PHK624426S, PHK624427S, PHK624428S, PHK624429S, PHK624430S, PHK624431S, PHK624432S, PHK624433S, PHK624434S, PHK624435S, PHK624436S, PHK624437S, PHK624438S, PHK624439S, PHK624440S, PHK624441S, PHK624443S, PHK624444S, PHK624445S, PHK624446S, PHK624447S, PHK624448S, PHK624449S, PHK624450S, PHK624451S, PHK624452S, PHK624453S, PHK624454S, PHK624455S, PHK624456S, PHK624457S, PHK624458S, PHK624459S, PHK624460S, PHK624461S, PHK624462S, PHK624463S, PHK624464S, PHK624465S, PHK624466S, PHK624467S, PHK624468S, PHK624469S, PHK624470S, PHK624471S, PHK624472S, PHK624473S, PHK624475S, PHK624476S, PHK624477S, PHK624478S, PHK624479S, PHK624480S, PHK624481S, PHK624482S, PHK624483S, PHK624484S, PHK624485S, PHK624486S, PHK624487S, PHK624488S, PHK624489S, PHK624490S, PHK624493S, PHK624494S, PHK624495S, PHK624496S, PHK624497S, PHK624498S, PHK624499S, PHK624500S, PHK624501S, PHK624502S, PHK624503S, PHK624504S, PHK624505S, PHK624506S, PHK624507S, PHK624508S, PHK624509S, PHK624510S, PHK624511S, PHK624512S, PHK624513S, PHK624514S, PHK624516S, PHK624517S, PHK624518S, PHK624519S, PHK624520S, PHK624521S, PHK624522S, PHK624523S, PHK624525S, PHK624526S, PHK624529S, PHK624530S, PHK624532S, PHK624533S, PHK624534S, PHK624535S, PHK624536S, PHK624537S, PHK624538S, PHK624539S, PHK624540S, PHK624541S, PHK624542S, PHK624543S, PHK624544S, PHK624545S, PHK624546S, PHK624548S, PHK624549S, PHK624550S, PHK624551S, PHK624552S, PHK624553S, PHK624554S, PHK624557S, PHK624558S, PHK624559S, PHK624560S, PHK624561S, PHK624562S, PHK624563S, PHK624564S, PHK624565S, PHK624566S, PHK624567S, PHK624568S, PHK624570S, PHK624571S, PHK624572S, PHK624573S, PHK624575S, PHK624576S, PHK624578S, PHK624580S, PHK624581S, PHK624582S, PHK624583S, PHK624584S, PHK624586S, PHK624587S, PHK624588S, PHK624589S, PHK624590S, PHK624591S, PHK624592S, PHK624593S, PHK624594S, PHK624595S, PHK624596S, PHK624597S, PHK624598S, PHK624600S, PHK624601S, PHK624603S, PHK624605S, PHK624607S, PHK624609S, PHK624610S, PHK624611S, PHK624612S, PHK624614S, PHK624615S, PHK624616S, PHK624618S, PHK624619S, PHK624620S, PHK624621S, PHK624622S, PHK624623S, PHK624624S, PHK624625S, PHK624626S, PHK624627S, PHK624628S, PHK624629S, PHK624630S, PHK624631S, PHK624632S, PHK624633S, PHK624634S, PHK624635S, PHK624637S, PHK624638S, PHK624639S, PHK624640S, PHK624641S, PHK624642S, PHK624643S, PHK624644S, PHK624645S, PHK624646S, PHK624647S, PHK624648S, PHK624649S, PHK624651S, PHK624652S, PHK624653S, PHK624654S, PHK624655S, PHK624656S, PHK624657S, PHK624658S, PHK624659S, PHK624660S, PHK624661S, PHK624662S, PHK624663S, PHK624664S, PHK624665S, PHK624666S, PHK624667S, PHK624668S, PHK624669S, PHK624670S, PHK624671S, PHK624672S, PHK624673S, PHK624674S, PHK624675S, PHK624676S, PHK624677S, PHK624678S, PHK624679S, PHK624680S, PHK624681S, PHK624683S, PHK624684S, PHK624685S, PHK624686S, PHK624687S, PHK624688S, PHK624689S, PHK624690S, PHK624691S, PHK624692S, PHK624693S, PHK624694S, PHK624695S, PHK624696S, PHK624697S, PHK624698S, PHK624699S, PHK624700S, PHK624701S, PHK624702S, PHK624703S, PHK624704S, PHK624705S, PHK624706S, PHK624707S, PHK624708S, PHK624709S, PHK624710S, PHK624711S, PHK624712S, PHK624713S, PHK624714S, PHK624715S, PHK624716S, PHK624717S, PHK624718S, PHK624719S, PHK624720S, PHK624721S, PHK624722S, PHK624723S, PHK624724S, PHK624725S, PHK624726S, PHK624727S, PHK624728S, PHK624729S, PHK624730S, PHK624731S, PHK624732S, PHK624733S, PHK624734S, PHK624735S, PHK624736S, PHK624737S, PHK624738S, PHK624739S, PHK624740S, PHK624741S, PHK624742S, PHK624743S, PHK624744S, PHK624745S, PHK624746S, PHK624747S, PHK624748S, PHK624749S, PHK624750S, PHK624751S, PHK624752S, PHK624753S, PHK624754S, PHK624755S, PHK624756S, PHK624757S, PHK624758S, PHK624759S, PHK624760S, PHK624761S, PHK624762S, PHK624763S, PHK624764S, PHK624766S, PHK624767S, PHK624768S, PHK624769S, PHK624770S, PHK624772S, PHK624773S, PHK624774S, PHK624775S, PHK624776S, PHK624777S, PHK624778S, PHK624779S, PHK624780S, PHK624781S, PHK624782S, PHK624783S, PHK624784S, PHK624785S, PHK624786S, PHK624787S, PHK624788S, PHK624789S, PHK624790S, PHK624791S, PHK624792S, PHK624793S, PHK624795S, PHK624796S, PHK624797S, PHK624798S, PHK624799S, PHK624800S, PHK624801S, PHK624802S, PHK624803S, PHK624804S, PHK624805S, PHK624806S, PHK624807S, PHK624808S, PHK624809S, PHK624810S, PHK624811S, PHK624812S, PHK624813S, PHK624814S, PHK624815S, PHK624816S, PHK624817S, PHK624818S, PHK624819S, PHK624820S, PHK624821S, PHK624822S, PHK624823S, PHK624824S, PHK624825S, PHK624826S, PHK624827S, PHK624829S, PHK624830S, PHK624831S, PHK624832S, PHK624833S, PHK624834S, PHK624835S, PHK624836S, PHK624837S, PHK624838S, PHK624840S, PHK624841S, PHK624842S, PHK624843S, PHK624844S, PHK624845S, PHK624846S, PHK624847S, PHK624848S, PHK624849S, PHK624850S, PHK624851S, PHK624852S, PHK624853S, PHK624854S, PHK624855S, PHK624856S, PHK624857S, PHK624858S, PHK624859S, PHK624860S, PHK624861S, PHK624862S, PHK624863S, PHK624864S, PHK624865S, PHK624866S, PHK624867S, PHK624868S, PHK624869S, PHK624870S, PHK624871S, PHK624872S, PHK624873S, PHK624874S, PHK624875S, PHK624876S, PHK624877S, PHK624878S, PHK624879S, PHK624880S, PHK624881S, PHK624882S, PHK624883S, PHK624884S, PHK624885S, PHK624886S, PHK624887S, PHK624888S, PHK624889S, PHK624890S, PHK624891S, PHK624892S, PHK624893S, PHK624894S, PHK624896S, PHK624897S, PHK624898S, PHK624899S, PHK624900S, PHK624901S, PHK624902S, PHK624903S, PHK624904S, PHK624905S, PHK624906S, PHK624907S, PHK624908S, PHK624909S, PHK624910S, PHK624911S, PHK624912S, PHK624913S, PHK624914S, PHK624915S, PHK624917S, PHK624918S, PHK624919S, PHK624920S, PHK624921S, PHK624922S, PHK624923S, PHK624924S, PHK624925S, PHK624926S, PHK624927S, PHK624928S, PHK624929S, PHK624930S, PHK624931S, PHK624932S, PHK624933S, PHK624934S, PHK624935S, PHK624936S, PHK624937S, PHK624938S, PHK624939S, PHK624940S, PHK624941S, PHK624942S, PHK624943S, PHK624945S, PHK624946S, PHK624947S, PHK624948S, PHK624949S, PHK624951S, PHK624952S, PHK624953S, PHK624954S, PHK624955S, PHK624956S, PHK624957S, PHK624958S, PHK624959S, PHK624960S, PHK624961S, PHK624962S, PHK624963S, PHK624964S, PHK624965S, PHK624966S, PHK624967S, PHK624968S, PHK624969S, PHK624970S, PHK624971S, PHK624972S, PHK624973S, PHK624974S, PHK624976S, PHK624977S, PHK624978S, PHK624979S, PHK624980S, PHK624981S, PHK624982S, PHK624983S, PHK624984S, PHK624985S, PHK624986S, PHK624987S, PHK624988S, PHK624989S, PHK624990S, PHK624991S, PHK624992S, PHK624993S, PHK624994S, PHK624997S, PHK624998S, PHK624999S, PHK625000S, PHK625001S, PHK625003S, PHK625004S, PHK625005S, PHK625006S, PHK625007S, PHK625008S, PHK625009S, PHK625010S, PHK625011S, PHK625013S, PHK625014S, PHK625015S, PHK625017S, PHK625018S, PHK625019S, PHK625020S, PHK625021S, PHK625022S, PHK625023S, PHK625025S, PHK625026S, PHK625027S, PHK625029S, PHK625030S, PHK625031S, PHK625032S, PHK625033S, PHK625034S, PHK625035S, PHK625036S, PHK625037S, PHK625038S, PHK625039S, PHK625042S, PHK625043S, PHK625044S, PHK625045S, PHK625046S, PHK625047S, PHK625048S, PHK625049S, PHK625051S, PHK625052S, PHK625053S, PHK625054S, PHK625055S, PHK625056S, PHK625057S, PHK625059S, PHK625061S, PHK625062S, PHK625063S, PHK625064S, PHK625065S, PHK625066S, PHK625067S, PHK625068S, PHK625069S, PHK625070S, and PHK625071S.   Model KD703, serial numbers: PHM621134S, PHM621146S, PHM621186S, PHM621187S, PHM621188S, PHM621189S, PHM621190S, PHM621191S, PHM621192S, PHM621194S, PHM621195S, PHM621196S, PHM621197S, PHM621198S, PHM621199S, PHM621200S, PHM621201S, PHM621202S, PHM621203S, PHM621204S, PHM621205S, PHM621206S, PHM621207S, PHM621208S, PHM621209S, PHM621210S, PHM621211S, PHM621212S, PHM621213S, PHM621214S, PHM621215S, PHM621216S, PHM621217S, PHM621218S, PHM621219S, PHM621220S, PHM621221S, PHM621222S, PHM621223S, PHM621224S, PHM621225S, PHM621226S, PHM621227S, PHM621228S, PHM621230S, PHM621231S, PHM621232S, PHM621234S, PHM621235S, PHM621236S, PHM621237S, PHM621238S, PHM621239S, PHM621241S, PHM621242S, PHM621243S, PHM621244S, PHM621245S, PHM621246S, PHM621247S, PHM621248S, PHM621249S, PHM621250S, PHM621251S, PHM621252S, PHM621254S, PHM621255S, PHM621256S, PHM621257S, PHM621258S, PHM621261S, PHM621262S, PHM621263S, PHM621264S, PHM621265S, PHM621266S, PHM621267S, PHM621268S, PHM621269S, PHM621270S, PHM621271S, PHM621272S, PHM621273S, PHM621274S, PHM621275S, PHM621276S, PHM621277S, PHM621278S, PHM621279S, PHM621280S, PHM621281S, PHM621282S, PHM621283S, PHM621284S, PHM621285S, PHM621286S, PHM621287S, PHM621288S, PHM621289S, PHM621290S, PHM621291S, PHM621292S, PHM621293S, PHM621294S, PHM621295S, PHM621296S, PHM621297S, PHM621298S, PHM621299S, PHM621300S, PHM621301S, PHM621302S, PHM621303S, PHM621304S, PHM621305S, PHM621306S, PHM621307S, PHM621308S, PHM621309S, PHM621310S, PHM621311S, PHM621312S, PHM621313S, PHM621315S, PHM621316S, PHM621317S, PHM621318S, PHM621319S, PHM621320S, PHM621322S, PHM621323S, PHM621324S, PHM621325S, PHM621326S, PHM621327S, PHM621328S, PHM621330S, PHM621331S, PHM621332S, PHM621333S, PHM621334S, PHM621335S, PHM621336S, PHM621337S, PHM621338S, PHM621339S, PHM621340S, PHM621341S, PHM621342S, PHM621343S, PHM621344S, PHM621345S, PHM621346S, PHM621347S, PHM621348S, PHM621349S, PHM621350S, PHM621351S, PHM621352S, PHM621353S, PHM621354S, PHM621355S, PHM621356S, PHM621357S, PHM621358S, PHM621359S, PHM621360S, PHM621361S, PHM621362S, PHM621363S, PHM621364S, PHM621365S, PHM621366S, PHM621367S, PHM621368S, PHM621369S, PHM621370S, PHM621372S, PHM621373S, PHM621374S, PHM621375S, PHM621376S, PHM621377S, PHM621378S, PHM621379S, PHM621380S, PHM621381S, PHM621383S, PHM621384S, PHM621385S, PHM621387S, PHM621388S, PHM621389S, PHM621390S, PHM621391S, PHM621392S, PHM621395S, PHM621397S, PHM621398S, PHM621399S, PHM621400S, PHM621401S, PHM621402S, PHM621403S, PHM621404S, PHM621405S, PHM621406S, PHM621407S, PHM621408S, PHM621409S, PHM621410S, PHM621411S, PHM621412S, PHM621413S, PHM621414S, PHM621415S, PHM621416S, PHM621417S, PHM621418S, PHM621419S, PHM621420S, PHM621421S, PHM621422S, PHM621423S, PHM621424S, PHM621425S, PHM621426S, PHM621427S, PHM621428S, PHM621429S, PHM621432S, PHM621433S, PHM621434S, PHM621435S, PHM621436S, PHM621437S, PHM621438S, PHM621439S, PHM621440S, PHM621441S, PHM621442S, PHM621443S, PHM621444S, PHM621445S, PHM621446S, PHM621447S, PHM621448S, PHM621449S, PHM621452S, PHM621453S, PHM621454S, PHM621455S, PHM621456S, PHM621457S, PHM621458S, PHM621459S, PHM621460S, PHM621461S, PHM621462S, PHM621464S, PHM621466S, PHM621467S, PHM621468S, PHM621470S, PHM621471S, PHM621472S, PHM621473S, PHM621474S, PHM621475S, PHM621476S, PHM621477S, PHM621478S, PHM621479S, PHM621480S, PHM621481S, PHM621482S, PHM621483S, PHM621484S, PHM621485S, PHM621486S, PHM621487S, PHM621488S, PHM621489S, PHM621490S, PHM621491S, PHM621492S, PHM621493S, PHM621494S, PHM621495S, PHM621496S, PHM621497S, PHM621498S, PHM621499S, PHM621500S, PHM621501S, PHM621502S, PHM621503S, PHM621504S, PHM621505S, PHM621506S, PHM621507S, PHM621508S, PHM621509S, PHM621510S, PHM621511S, PHM621512S, PHM621513S, PHM621514S, PHM621515S, PHM621516S, PHM621517S, PHM621518S, PHM621519S, and PHM621520S.   Model KD706, serial numbers: PHL620280S, PHL620282S, PHL620284S, PHL620285S, PHL620286S, PHL620288S, PHL620289S, PHL620290S, PHL620291S, PHL620292S, PHL620294S, PHL620295S, PHL620296S, PHL620299S, PHL620301S, PHL620302S, PHL620303S, PHL620304S, PHL620305S, PHL620306S, PHL620307S, PHL620308S, PHL620309S, and PHL620311S,   
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
Manufacturer Reason
for Recall
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
FDA Determined
Cause 2
Device Design
Action Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
Quantity in Commerce 1281
Distribution Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NVZ and Original Applicant = MEDTRONIC Inc.