Z-1513-2009

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

Name: Z-1513-2009 Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701...
Creator: Medtronic Inc. Cardiac Rhythm Disease Managment
Published: 2009-05-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-05-18 / Terminated / root cause: design

FDA source

Medtronic Inc. Cardiac Rhythm Disease Managment began a recall of Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706 on 2009-05-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1513-2009
Status: Terminated
Initiated: 2009-05-18
Posted: 2009-06-11
Terminated: 2012-03-28
Recalling firm: Medtronic, Inc.
Product: Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.
Product code: NVZ Pulse Generator, Permanent, Implantable
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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 code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)