Devices

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

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

One device with a similar name

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Device Recall Medtronic KAPPA 600/700/900 Series Implantable Pulse Generators (IPGs)
  • Model / Serial
    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,
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment