Medtronic Inc. Cardiac Rhythm Disease Managment: Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.

Recall number

Z-1513-2009

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Product

Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.

Status

Terminated

Initiated

2009-05-18

Posted

2009-06-11

Terminated

2012-03-28

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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,

510(k) numbers

not on file

PMA numbers

["P980035S031"]

Product code

NVZ

Firm FEI

2182208

Firm city

Saint Paul

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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