Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1721-2023
• Recall Event ID: 92328
• PMA Number: P980016S713
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S, RSL602048S, RSL602049S, RSL602050S, RSL602051S, RSL602052S, RSL602053S, RSL602054S, RSL602055S, RSL602056S, RSL602058S, RSL602059S, RSL602221S, RSL602222S, RSL602223S, RSL602224S, RSL602225S, RSL602227S, RSL602228S, RSL602229S, RSL602230S, RSL602231S, RSL602232S, RSL603256S, RSL603258S, RSL603259S, RSL603260S, RSL603261S, RSL601338S, RSL601339S, RSL601386S, RSL601434S, RSL601624S, RSL601626S, RSL601627S, RSL601628S, RSL601629S, RSL601630S, RSL601631S, RSL601632S, RSL601633S, RSL601634S, RSL601635S, RSL601636S, RSL602812S, RSL601370S, RSL601642S, RSL603153S, RSL602352S, RSL602422S, RSL602807S, RSL603126S, RSL603207S, RSL600336S, RSL600344S, RSL600407S, RSL600429S, RSL600809S, RSL601609S, RSL601698S, RSL601730S, RSL601800S, RSL601996S, RSL602171S, RSL602189S, RSL603606S, RSL602932S, RSL603159S, RSL603160S, RSL603253S, RSL603096S, RSL601651S, RSL601983S, RSL603133S, RSL601441S, RSL602289S, RSL602336S, RSL600605S, RSL601938S, RSL602067S, RSL602559S, RSL603597S, RSL603598S, RSL601708S, RSL600411S, RSL601749S, RSL601750S, RSL601851S, RSL603084S, RSL601506S, RSL602187S, RSL600484S, RSL601439S, RSL600342S, RSL602802S, RSL602918S, RSL603136S, RSL600624S, RSL601956S, RSL603131S, RSL600648S, RSL600658S, RSL601896S, RSL603640S, RSL602516S, RSL602515S, RSL603266S, RSL602226S, RSL602328S, RSL602293S, RSL603155S, RSL603810S, RSL602907S, RSL601980S, RSL602196S, RSL600397S, RSL600226S, RSL601621S, RSL601656S, RSL600156S, RSL600705S, RSL601637S, RSL601705S, RSL601387S, RSL601505S, RSL600195S, RSL600583S, RSL603286S, RSL603287S, RSL601511S, RSL600687S, RSL600444S, RSL600289S, RSL602551S, RSL602874S, RSL602978S, RSL602010S, RSL602011S, RSL602012S, RSL602013S, RSL602014S, RSL602016S, RSL602017S, RSL602018S, RSL602033S, RSL602034S, RSL602063S, RSL602241S, RSL602242S, RSL602243S, RSL602244S, RSL602245S, RSL602246S, RSL602247S, RSL602248S, RSL602249S, RSL602250S, RSL603706S, RSL603707S, RSL603708S, RSL603709S, RSL600154S, RSL600168S, RSL600194S, RSL600203S, RSL600268S, RSL600387S, RSL600401S, RSL600402S, RSL600403S, RSL600410S, RSL600423S, RSL600466S, RSL600599S, RSL600716S, RSL601713S, RSL601765S, RSL601840S, RSL601854S, RSL601855S, RSL602713S, RSL603280S, RSL603281S, RSL602354S, RSL602702S, RSL603161S, RSL600455S, RSL600618S, RSL600619S, RSL600664S, RSL602006S, RSL602007S, RSL602182S, RSL603764S, RSL602428S, RSL600152S, RSL600153S, RSL600390S, RSL600802S, RSL601865S, RSL601982S, RSL600581S, RSL600612S, RSL601497S, RSL601937S, RSL603663S, RSL603714S, RSL600610S, RSL600283S, RSL601853S, RSL603209S, RSL600491S, RSL601665S, RSL602530S, RSL601603S, RSL601752S, RSL601786S, RSL601799S, RSL602185S, RSL603592S, RSL602268S, RSL602274S, RSL602291S, RSL602439S, RSL601917S, RSL601928S, RSL602258S, RSL602259S, RSL602276S, RSL602290S, RSL602292S, RSL602438S, RSL602321S, RSL602322S, RSL603175S, RSL602177S, RSL601376S, RSL601755S, RSL602816S, RSL602817S, RSL600150S, RSL600241S, RSL601445S, RSL602938S, RSL600509S, RSL601611S, RSL601612S, RSL601726S, RSL600640S, RSL602482S, RSL602183S, RSL602480S, RSL602481S, RSL602483S, RSL602484S, RSL602680S, RSL600644S, RSL602533S, RSL601638S, RSL601707S, RSL601997S, RSL603125S, RSL600440S, RSL600663S, RSL601372S, RSL601379S, RSL601751S, RSL602724S, RSL602756S, RSL602839S, RSL602840S, RSL602929S, RSL602930S, RSL602485S, RSL602486S, RSL602908S, RSL603223S, RSL600504S, RSL600606S, RSL600788S, RSL601516S, RSL601380S, RSL602693S, RSL603652S, RSL601500S, RSL600326S, RSL601351S, RSL601777S, RSL603215S, RSL601747S, RSL601802S, RSL601494S, RSL603595S, RSL601680S, RSL601709S, RSL601798S, RSL602535S, RSL603134S, RSL601979S, RSL600348S, RSL603254S, RSL602302S, RSL602426S, RSL602427S, RSL602553S, RSL602709S, RSL602835S, RSL602843S, RSL602851S, RSL602914S, RSL603723S, RSL601555S, RSL601773S, RSL602061S, RSL602062S, RSL602064S, RSL603775S, RSL603648S, RSL603691S, RSL601688S, RSL601614S, RSL602299S, RSL601346S, RSL601660S, RSL601492S, RSL600473S, RSL603138S, RSL601942S, RSL602539S, RSL602841S, RSL603658S, RSL603120S, RSL602719S, RSL602188S, RSL603650S, RSL600238S, RSL600251S, RSL600256S, RSL600296S, RSL603162S, RSL602170S, RSL602042S, RSL603035S, RSL603036S, RSL600730S, RSL600746S, RSL603573S, RSL601847S, RSL600360S, RSL600666S, RSL601381S, RSL601435S, RSL601740S, RSL602423S, RSL602895S, RSL603109S, RSL603154S, RSL603267S, RSL600196S, RSL600298S, RSL601718S, RSL601869S, RSL603087S, RSL601759S, RSL603104S, RSL602495S, RSL602911S, RSL602869S, RSL603088S, RSL603197S, RSL603724S, RSL603725S, RSL603798S, RSL603799S, RSL600356S, RSL602909S, RSL600264S, RSL601669S, RSL601722S, RSL601932S, RSL601946S, RSL602174S, RSL603246S, RSL602440S, RSL602065S, RSL602561S, RSL602583S, RSL602848S, RSL602849S, RSL602711S, RSL603247S, RSL603581S, RSL603582S, RSL603796S, RSL603797S, RSL603563S, RSL602862S, RSL600334S, RSL600396S, RSL601857S, RSL603807S, RSL603613S, RSL600193S, RSL601712S, RSL601827S, RSL601643S, RSL602487S, RSL603642S, RSL601958S, RSL601808S, RSL603211S, RSL601959S, RSL602184S, RSL603609S, RSL603638S, RSL601714S, RSL601689S, RSL602922S, RSL603721S, RSL602344S, RSL603288S, RSL603289S, RSL602186S, RSL600626S, RSL601495S, RSL601496S, RSL601812S, RSL602253S, RSL603055S, RSL603795S, RSL602329S, RSL602335S, RSL603627S, RSL602714S, RSL603102S, RSL603651S, RSL603692S, RSL600290S, RSL600316S, RSL601771S, RSL601811S, RSL601815S, RSL601951S, RSL601725S, RSL603284S, RSL603285S, RSL602430S, RSL603009S, RSL600185S, RSL600213S, RSL600447S, RSL600613S, RSL600614S, RSL600659S, RSL600677S, RSL600765S, RSL601770S, RSL601785S, RSL602173S, RSL602180S, RSL602255S, RSL602256S, RSL602435S, RSL601334S, RSL601608S, RSL601774S, RSL601841S, RSL602181S, RSL603065S, RSL603590S, RSL601606S, RSL601731S, RSL602083S, RSL602198S, RSL602199S, RSL602200S, RSL602455S, RSL602456S, RSL602457S, RSL602458S, RSL602461S, RSL602462S, RSL602463S, RSL601717S, RSL601719S, RSL602459S, RSL602460S, RSL602464S, RSL600486S, RSL603098S, RSL602541S, RSL602688S, RSL603214S, RSL602193S, RSL600232S, RSL602861S, RSL603166S, RSL602925S, RSL602550S, RSL602704S, RSL600214S, RSL602009S, RSL603438S, RSL600551S, RSL603170S, RSL603732S, RSL601652S, RSL601436S, RSL603635S, RSL603636S, RSL603204S, RSL601512S, RSL601964S, RSL601957S, RSL601711S, RSL602497S, RSL602520S, RSL601715S, RSL602764S, RSL602765S, RSL602926S, RSL600487S, RSL601804S, RSL601844S, RSL603690S, RSL601605S, RSL602447S, RSL601746S, RSL601780S, RSL601781S, RSL600544S, RSL603152S, RSL602799S, RSL603074S, RSL601645S, RSL601862S, RSL601962S, RSL602434S, RSL603665S, RSL602192S, RSL603649S, RSL600472S, RSL601822S, RSL601823S, RSL601940S, RSL603676S, RSL601342S, RSL601805S, RSL601330S, RSL600542S, RSL600602S, RSL602496S, RSL601830S, RSL602179S, RSL602868S, RSL602915S, RSL603122S, RSL601934S, RSL602176S, RSL603164S, RSL603216S, RSL603771S, RSL603183S, RSL601331S, RSL601998S, RSL602526S, RSL600320S, RSL600346S, RSL600710S, RSL600715S, RSL601619S, RSL601658S, RSL601735S, RSL603670S, RSL600280S, RSL601757S, RSL602697S, RSL603165S, RSL601475S, RSL601489S, RSL601513S, RSL601835S, RSL603794S, RSL602277S, RSL602288S, RSL602347S, RSL602449S, RSL602450S, RSL602451S, RSL602452S, RSL602556S, RSL601795S, RSL601796S, RSL601831S, RSL601832S, RSL601834S, RSL601836S, RSL601837S, RSL601907S, RSL601930S, RSL601931S, RSL602032S, RSL602163S, RSL602239S, RSL602694S, RSL602803S, RSL602805S, RSL602813S, RSL602920S, RSL602921S, RSL603083S, RSL603137S, RSL603240S, RSL601348S, RSL600584S, RSL601344S, RSL602528S, RSL602699S, RSL602825S, RSL603158S, RSL603174S, RSL601582S, RSL601819S, RSL601820S, RSL601843S, RSL600149S, RSL600690S, RSL603005S, RSL601721S, RSL601760S, RSL600208S, RSL602441S, RSL602882S, RSL602883S, RSL602884S, RSL601533S, RSL601539S, RSL601544S, RSL601554S, RSL602068S, RSL602069S, RSL602880S, RSL602881S, RSL602294S, RSL602073S, RSL602074S, RSL600541S, RSL600586S, RSL601442S, RSL602076S, RSL602976S, RSL601963S, RSL602077S, RSL602164S, RSL603234S, RSL601345S, RSL601478S, RSL601520S, RSL602425S, RSL602852S, RSL603200S, RSL603584S, RSL600036S, RSL600165S, RSL600220S, RSL600224S, RSL600328S, RSL601663S, RSL601685S, RSL601778S, RSL603227S, RSL603800S, RSL602741S, RSL601813S, RSL602592S, RSL602768S, RSL602931S, RSL600629S, RSL600816S, RSL602898S, RSL603195S, RSL602075S, RSL600442S, RSL601729S, RSL602936S, RSL601672S, RSL601343S, RSL600434S, RSL600536S, RSL600537S, RSL600538S, RSL600556S, RSL600718S, RSL600790S, RSL600820S, RSL603235S, RSL603245S, RSL600228S, RSL601245S, RSL602190S, RSL601595S, RSL601600S, RSL602845S, RSL603585S, RSL602424S, RSL602896S, RSL601545S, RSL602305S, RSL602857S, RSL602809S, RSL601975S, RSL601828S, RSL601756S, RSL600292S, RSL600643S, RSL601657S, RSL601670S, RSL600681S, RSL600682S, RSL601981S, RSL602003S, RSL602353S, RSL602525S, RSL601734S, RSL602797S, RSL602691S, RSL601613S, RSL602517S, RSL603292S, RSL602240S, RSL603275S, RSL603291S, RSL602552S, RSL602838S, RSL602856S, RSL600253S, RSL600282S, RSL600345S, RSL600683S, RSL600806S, RSL601527S, RSL601691S, RSL601936S, RSL603587S, RSL600217S, RSL600520S, RSL600521S, RSL600593S, RSL600704S, RSL603662S, RSL601679S, RSL601681S, RSL601716S, RSL601885S, RSL601945S, RSL601994S, RSL601995S, RSL602039S, RSL602080S, RSL602085S, RSL602111S, RSL600465S, RSL601335S, RSL600463S, RSL600660S, RSL600337S, RSL600363S, RSL600364S, RSL600365S, RSL600372S, RSL600490S, RSL600539S, RSL600598S, RSL601724S, RSL601739S, RSL603156S, RSL603196S, RSL600181S, RSL603283S, RSL600335S, RSL603282S, RSL602836S, RSL600242S, RSL600269S, RSL601655S, RSL602718S, RSL602537S, RSL603111S, RSL602271S, RSL600675S, RSL601389S, RSL601748S, RSL603647S, RSL602928S, RSL600351S, RSL600416S, RSL600488S, RSL600588S, RSL600634S, RSL603097S, RSL601742S, RSL603705S, RSL603685S, RSL601693S, RSL601772S, RSL603718S, RSL602538S, RSL603604S, RSL603643S, RSL601969S, RSL601999S, RSL602257S, RSL603603S, RSL600323S, RSL600652S, RSL600700S, RSL600331S, RSL603290S, RSL603562S, RSL600620S, RSL602703S, RSL602830S, RSL603232S, RSL603212S, RSL603686S, RSL602916S, RSL603149S, RSL602912S, RSL600785S, RSL600787S, RSL602079S, RSL603225S, RSL603668S, RSL603697S, RSL601525S, RSL603580S, RSL602071S, RSL601826S, RSL601993S, RSL603265S, RSL602700S, RSL600244S, RSL600246S, RSL600249S, RSL601522S, RSL601646S, RSL601736S, RSL602878S, RSL602879S, RSL602970S, RSL601446S, RSL601970S, RSL603631S, RSL603056S, RSL601371S, RSL601493S, RSL601654S, RSL601696S, RSL601697S, RSL601733S, RSL601793S, RSL601817S, RSL601967S, RSL602191S, RSL603270S, RSL603661S, RSL603144S, RSL600174S, RSL600272S, RSL600314S, RSL601523S, RSL601787S, RSL601788S, RSL601790S, RSL601825S, RSL601833S, RSL601856S, RSL601871S, RSL603821S, RSL602432S, RSL602436S, RSL602910S, RSL600240S, RSL600679S, RSL600684S, RSL600703S, RSL601671S, RSL601727S, RSL601797S, RSL601972S, RSL602023S, RSL602036S, RSL602251S, RSL602304S, RSL602421S, RSL602755S, RSL603121S, RSL603755S, RSL600184S, RSL600480S, RSL601692S, RSL601758S, RSL601927S, RSL601929S, RSL602834S, RSL603601S, RSL603607S, RSL600623S, RSL600631S, RSL600632S, RSL601818S, RSL602002S, RSL602019S, RSL602025S, RSL603034S, RSL603558S, RSL603559S, RSL603446S, RSL603557S, RSL602819S, RSL602443S, RSL602548S, RSL603625S, RSL603737S, RSL603220S, RSL603221S, RSL601852S, RSL601941S, RSL601710S, RSL601864S, RSL602070S, RSL602195S, RSL602531S, RSL602636S, RSL602806S, RSL602821S, RSL603622S, RSL600192S, RSL600676S, RSL601470S, RSL601615S, RSL601678S, RSL601694S, RSL601703S, RSL601706S, RSL601863S, RSL601991S, RSL603656S, RSL603808S, RSL600554S, RSL600517S, RSL600709S, RSL602542S, RSL600607S, RSL603107S, RSL603173S, RSL603623S, RSL601647S, RSL602510S, RSL602433S, RSL600558S, RSL603066S, RSL600329S, RSL601429S, RSL600568S, RSL603179S, RSL601448S, RSL601690S, RSL601794S, RSL601791S, RSL601810S, RSL601985S, RSL602178S, RSL602194S, RSL600312S, RSL603187S, RSL601849S, RSL603151S, RSL601954S, RSL602078S, RSL602695S, RSL601960S, RSL602712S, RSL600281S, RSL601519S, RSL601846S, RSL603255S, RSL601977S, RSL602701S, RSL600503S, RSL600655S, RSL600719S, RSL600772S, RSL602858S, RSL600175S, RSL600267S, RSL600378S, RSL601664S, RSL602924S, RSL603238S, RSL603610S, RSL601641S, RSL601848S, RSL600191S, RSL601649S, RSL603785S, RSL600594S, RSL602842S, RSL602853S, RSL603069S, RSL603168S, RSL601744S, RSL603616S, RSL603756S, RSL602417S, RSL601947S, RSL602877S, RSL601763S, RSL602437S, RSL602886S, RSL603383S, RSL603007S, RSL602357S, RSL602518S, RSL602534S, RSL603190S, RSL600321S, RSL600366S, RSL600395S, RSL600506S, RSL600654S, RSL600678S, RSL601618S, RSL602445S, RSL602446S, RSL602511S, RSL602512S, RSL602875S, RSL601332S, RSL601337S, RSL601948S, RSL601949S, RSL601952S, RSL601955S, RSL602237S, RSL602238S, RSL602876S, RSL602991S, RSL602992S, RSL601989S, RSL602340S, RSL602814S, RSL600162S, RSL600222S, RSL600223S, RSL600285S, RSL600468S, RSL600698S, RSL601347S, RSL601384S, RSL601480S, RSL601518S, RSL601700S, RSL601701S, RSL601702S, RSL601769S, RSL601801S, RSL601939S, RSL603593S, RSL602810S, RSL602820S, RSL603163S, RSL603177S, RSL601508S, RSL601741S, RSL601803S, RSL601824S, RSL602038S, RSL602175S, RSL603194S, RSL603765S, RSL600672S, RSL603311S, RSL603315S, RSL603316S, RSL603328S, RSL603333S, RSL603338S, RSL603349S, RSL603355S, RSL603359S, RSL603360S, RSL603361S, RSL603362S, RSL603368S, RSL603377S, RSL603380S, RSL603382S, RSL603786S, RSL603788S, RSL603789S, RSL603791S, RSL603792S, RSL602543S, RSL603210S, RSL602692S, RSL601860S, RSL601992S, RSL600650S, RSL602800S, RSL600757S, RSL601616S, RSL603825S, RSL601661S, RSL601507S, RSL601514S, RSL603101S, RSL603157S, RSL601526S, RSL600432S, RSL600433S, RSL602846S, RSL603567S, RSL603568S, RSL600260S, RSL600601S, RSL600630S, RSL601640S, RSL600404S, RSL600467S, RSL600574S, RSL600210S, RSL600341S, RSL600714S, RSL601650S, RSL601965S, RSL602015S, RSL603673S, RSL603072S, RSL602035S, RSL601695S, RSL600383S, RSL602560S, RSL602252S, RSL601437S, RSL601502S, RSL601503S, RSL603666S, RSL601821S, RSL600178S, RSL602815S, RSL601620S, RSL603439S, RSL603440S, RSL603442S, RSL603443S, RSL603444S, RSL603445S, RSL600317S, RSL600446S, RSL600522S, RSL603386S, RSL603387S, RSL603388S, RSL603389S, RSL603390S, RSL603392S, RSL602479S, RSL602477S, RSL602478S, RSL602489S, RSL602490S, RSL602494S, RSL602782S, RSL602784S, RSL602785S, RSL602786S, RSL602788S, RSL602790S, RSL602791S, RSL602793S, RSL602794S, RSL602795S, RSL603010S, RSL603011S, RSL603012S, RSL603420S, RSL603421S, RSL603422S, RSL603423S, RSL603575S, RSL603576S, RSL603578S, RSL603579S, RSL600338S, RSL600547S, RSL603228S, RSL603229S, RSL603230S, RSL603231S, RSL603384S, RSL603385S, RSL603704S, RSL602871S, RSL602873S, RSL602962S, RSL603248S, RSL603274S, RSL603304S, RSL603305S, RSL603306S, RSL603308S, RSL603309S, RSL600422S, RSL602066S, RSL601842S, RSL602707S, RSL602984S, RSL602980S, RSL602982S, RSL603243S, RSL603244S, RSL602498S, RSL602540S, RSL601377S, RSL601625S, RSL601968S, RSL601859S, RSL603278S, RSL603279S, RSL602431S, RSL603271S, RSL601950S, RSL602286S, RSL602474S, RSL602475S, RSL602900S, RSL602902S, RSL602904S, RSL602906S, RSL602476S, RSL603427S, RSL603428S, RSL603429S, RSL603430S, RSL603431S, RSL603432S, RSL603433S, RSL603436S, RSL603437S, RSL603094S, RSL601816S, RSL603793S, RSL601764S, RSL601775S, RSL602885S, RSL602708S, RSL600376S, RSL600497S, RSL602837S, RSL602855S, RSL601943S, RSL601498S, RSL603226S, RSL603637S, RSL602829S, RSL600555S, RSL601622S, RSL601623S, RSL602169S, RSL602418S, RSL602913S, RSL603057S, RSL603605S, RSL600496S, RSL600304S, RSL600279S, RSL601453S, RSL601454S, RSL601639S, RSL601486S, RSL601648S, RSL603169S, RSL600176S, RSL601457S, RSL603167S, RSL600197S, RSL600198S, RSL601456S, RSL603178S, RSL600358S, RSL603062S, RSL602549S, RSL600236S, RSL602863S, RSL601662S, RSL602923S, RSL600313S, RSL600417S, RSL600435S, RSL600817S, RSL601861S, RSL601953S, RSL602723S, RSL602698S, RSL601872S, RSL603171S, RSL601768S, RSL602917S, RSL603664S, RSL600386S, RSL600755S, RSL601776S, RSL600405S, RSL602297S, RSL602939S, RSL603058S, RSL602519S, RSL603742S, RSL602801S, RSL600552S, RSL601845S, RSL601644S, RSL602415S, RSL600400S, RSL602864S, RSL603103S, RSL603757S, RSL601973S, RSL601659S, RSL603684S, RSL602419S, RSL603629S, RSL601720S, RSL601961S, RSL602888S, RSL602887S, RSL602865S, RSL601935S, RSL603180S, RSL603053S, RSL602833S, RSL603052S, RSL603061S, RSL603150S, RSL603674S, RSL600303S, RSL600535S, RSL600633S, RSL600636S, RSL601333S, RSL601743S, RSL601745S, RSL601806S, RSL601978S, RSL601984S, RSL602000S, RSL602001S, RSL602005S, RSL602254S, RSL601754S, RSL600413S, RSL600505S, RSL600507S, RSL601444S, RSL601779S, RSL600458S, RSL602860S, RSL603239S, RSL603653S, RSL600369S, RSL600370S, RSL600381S, RSL600448S, RSL600579S, RSL601524S, RSL601728S, RSL601732S, RSL601753S, RSL602536S, RSL602808S, RSL603076S, RSL603241S, RSL602037S, RSL602021S, RSL603814S, RSL601766S, RSL601866S, RSL602721S, RSL600339S, RSL600645S, RSL601517S, RSL602867S, RSL603702S, RSL601974S, RSL601986S, RSL601987S, RSL602527S, RSL601784S, RSL602285S, RSL601877S, RSL603394S, RSL603395S, RSL603397S, RSL603401S, RSL603403S, RSL603406S, RSL603408S, RSL603410S, RSL603411S, RSL603412S, RSL603413S, RSL603414S, RSL603417S, RSL603782S, RSL603783S, RSL603784S, RSL602269S, RSL602275S, RSL601509S, RSL602507S, RSL602508S, RSL602509S, RSL602555S, RSL602557S, RSL602558S, RSL603249S, RSL603272S, RSL603273S, RSL603276S, RSL603560S, RSL603561S, RSL603700S, RSL603701S, RSL602295S, RSL602529S, RSL602513S, RSL602514S, RSL602473S, RSL602891S, RSL602894S, RSL603038S, RSL603040S, RSL603041S, RSL603047S, RSL603051S, RSL603296S, RSL603301S, RSL603302S, RSL602453S, RSL602454S, RSL602499S, RSL602501S, RSL602502S, RSL602505S, RSL602506S, RSL602545S, RSL602607S, RSL602623S, RSL602728S, RSL602732S, RSL602750S, RSL602752S, RSL602753S, RSL602758S, RSL602770S, RSL602774S, RSL602778S, RSL600823S, RSL600825S, RSL600826S, RSL601350S, RSL601353S, RSL601355S, RSL601361S, RSL601362S, RSL601363S, RSL601364S, RSL601366S, RSL601368S, RSL601369S, RSL601374S, RSL601382S, RSL601431S, RSL601458S, RSL601462S, RSL601564S, RSL601610S, RSL601653S, RSL601673S, RSL601674S, RSL601675S, RSL601676S, RSL601677S, RSL601682S, RSL601683S, RSL601686S, RSL601687S, RSL601704S, RSL601914S, RSL602027S, RSL602028S, RSL602030S, RSL602041S, RSL602081S, RSL602082S, RSL602120S, RSL602157S, RSL602158S, RSL602159S, RSL602162S, RSL602165S, RSL602166S, RSL602167S, RSL602233S, RSL602234S, RSL602235S, RSL602236S, RSL602500S, RSL602503S, RSL602504S, RSL602544S, RSL602546S, RSL602547S, RSL602612S, RSL602615S, RSL602620S, RSL602621S, RSL602622S, RSL602624S, RSL602726S, RSL602744S, RSL602745S, RSL602751S, RSL602757S, RSL602769S, RSL602771S, RSL602773S, RSL602775S, RSL602777S, RSL602779S, RSL603015S, RSL603017S, RSL603018S, RSL603019S, RSL603021S, RSL603022S, RSL603023S, RSL603024S, RSL603025S, RSL603032S, RSL603033S, RSL603293S, RSL603294S, RSL603295S, RSL603509S, RSL603677S, RSL603678S, RSL603710S, RSL602866S, RSL601944S, RSL602760S, RSL602761S, RSL602762S, RSL602306S, RSL602308S, RSL602311S, RSL602312S, RSL602317S, RSL601515S, RSL603184S, RSL600723S, RSL603277S, RSL603250S, RSL603251S, RSL603252S, RSL603599S, RSL603628S, RSL603660S, RSL603734S, RSL602522S, RSL600375S, RSL602197S; GTIN 00763000178352, Lot Numbers: RSL601023S, RSL603552S, RSL603892S, RSL603508S, RSL603540S, RSL603078S, RSL602605S, RSL603572S, RSL602734S, RSL602572S, RSL602601S, RSL603564S, RSL603113S, RSL602990S, RSL601925S, RSL601568S, RSL600958S, RSL602567S, RSL602604S, RSL601207S, RSL601274S, RSL601465S, RSL601206S, RSL601208S, RSL601483S, RSL601471S, RSL602090S, RSL602649S, RSL602651S, RSL601264S, RSL601460S, RSL601594S, RSL600107S, RSL600124S, RSL602996S, RSL602985S, RSL603364S, RSL603463S, RSL603472S, RSL600874S, RSL600875S, RSL600878S, RSL600906S, RSL601081S, RSL601889S, RSL601898S, RSL601899S, RSL601919S, RSL600884S, RSL601007S, RSL601408S, RSL602410S, RSL602411S, RSL602776S, RSL602780S, RSL602759S, RSL602664S, RSL603110S, RSL603112S, RSL603492S, RSL600037S, RSL601069S, RSL601266S, RSL601270S, RSL602115S, RSL603050S, RSL603081S, RSL601203S, RSL601204S, RSL601591S, RSL602210S, RSL602598S, RSL600869S, RSL600158S, RSL600170S, RSL600450S, RSL600696S, RSL600833S, RSL601039S, RSL601320S, RSL601325S, RSL602105S, RSL602748S, RSL602974S, RSL602975S, RSL602999S, RSL602659S, RSL600042S, RSL600066S, RSL600083S, RSL601267S, RSL602994S, RSL603416S, RSL601467S, RSL601908S, RSL602004S, RSL602399S, RSL602613S, RSL602631S, RSL603073S, RSL600069S, RSL602204S, RSL600063S, RSL602089S, RSL602763S, RSL603501S, RSL603596S, RSL601906S, RSL601229S, RSL601031S, RSL601072S, RSL601199S, RSL601449S, RSL601474S, RSL602020S, RSL602217S, RSL600043S, RSL600064S, RSL600910S, RSL601005S, RSL601904S, RSL602098S, RSL602212S, RSL602408S, RSL602725S, RSL603093S, RSL601259S, RSL601271S, RSL601406S, RSL602112S, RSL602792S, RSL603500S, RSL600408S, RSL601024S, RSL601587S, RSL602717S, RSL601910S, RSL602977S, RSL601461S, RSL601584S, RSL600822S, RSL602168S, RSL601916S, RSL601275S, RSL601276S, RSL602632S, RSL602633S, RSL601911S, RSL601076S, RSL602818S, RSL602822S, RSL602099S, RSL602101S, RSL600846S, RSL601150S, RSL602104S, RSL600183S, RSL600813S, RSL601466S, RSL601537S, RSL601563S, RSL601567S, RSL601607S, RSL601881S, RSL602114S, RSL602562S, RSL602596S, RSL602731S, RSL602749S, RSL602798S, RSL602827S, RSL603059S, RSL603090S, RSL600077S, RSL600082S, RSL601241S, RSL601530S, RSL602599S, RSL603068S, RSL601258S, RSL603533S, RSL601015S, RSL601398S, RSL600894S, RSL600896S, RSL601034S, RSL601232S, RSL601239S, RSL601262S, RSL601573S, RSL601037S, RSL601082S, RSL601265S, RSL603029S, RSL601261S, RSL601321S, RSL601604S, RSL602564S, RSL601263S, RSL601399S, RSL601400S, RSL601476S, RSL601579S, RSL601601S, RSL602565S, RSL601146S, RSL601186S, RSL601565S, RSL601586S, RSL602606S, RSL601472S, RSL602972S, RSL603588S, RSL603404S, RSL600940S, RSL601175S, RSL601566S, RSL601583S, RSL601010S, RSL602091S, RSL602096S, RSL602591S, RSL601006S, RSL602647S, RSL600882S, RSL601100S, RSL602652S, RSL602416S, RSL600922S, RSL601008S, RSL601040S, RSL601913S, RSL602648S, RSL603002S, RSL601211S, RSL600840S, RSL601187S, RSL601451S, RSL600901S, RSL601531S, RSL603502S, RSL602767S, RSL602772S, RSL603453S, RSL601541S, RSL600812S, RSL600981S, RSL600993S, RSL600999S, RSL601534S, RSL602640S, RSL600044S, RSL601542S, RSL602102S, RSL603365S, RSL600815S, RSL600819S, RSL601257S, RSL602578S, RSL602766S, RSL603418S, RSL600868S, RSL602742S, RSL600807S, RSL601004S, RSL601432S, RSL602216S, RSL601464S, RSL600951S, RSL601185S, RSL602206S, RSL602211S, RSL602781S, RSL601145S, RSL601283S, RSL601312S, RSL601311S, RSL601329S, RSL602590S, RSL600930S, RSL601589S, RSL601124S, RSL601047S, RSL601110S, RSL602134S, RSL603555S, RSL601020S, RSL601042S, RSL601075S, RSL601138S, RSL601140S, RSL601450S, RSL603135S, RSL601130S, RSL601134S, RSL601142S, RSL601045S, RSL602118S, RSL602412S, RSL602589S, RSL603426S, RSL601354S, RSL603402S, RSL601403S, RSL601166S, RSL602131S, RSL602359S, RSL603529S, RSL601028S, RSL601153S, RSL601161S, RSL601070S, RSL601091S, RSL601488S, RSL602588S, RSL601401S, RSL601404S, RSL601084S, RSL602670S, RSL601129S, RSL602346S, RSL602382S, RSL601046S, RSL601123S, RSL601147S, RSL602374S, RSL603079S, RSL603132S, RSL602128S, RSL601127S, RSL601131S, RSL603538S, RSL601182S, RSL603545S, RSL601360S, RSL603519S, RSL601113S, RSL602388S, RSL601323S, RSL601098S, RSL601141S, RSL601144S, RSL603518S, RSL601132S, RSL601170S, RSL601029S, RSL601101S, RSL601156S, RSL601157S, RSL601158S, RSL602119S, RSL602130S, RSL602414S, RSL602675S, RSL603424S, RSL602372S, RSL601180S, RSL601219S, RSL602356S, RSL603139S, RSL601099S, RSL601358S, RSL601181S, RSL602371S, RSL602360S, RSL601035S, RSL601356S, RSL603140S, RSL601327S, RSL602327S, RSL602345S, RSL602355S, RSL602413S, RSL603080S, RSL601118S, RSL601089S, RSL601322S, RSL601102S, RSL601137S, RSL601375S, RSL601155S, RSL601174S, RSL602370S, RSL601071S, RSL601108S, RSL601143S, RSL601233S, RSL601120S, RSL602349S, RSL603425S, RSL601479S, RSL602219S, RSL601126S, RSL602666S, RSL602746S, RSL601405S, RSL601882S, RSL602406S, RSL602407S, RSL602831S, RSL602859S, RSL601197S, RSL601521S, RSL601012S, RSL601013S, RSL601016S, RSL601017S, RSL601009S, RSL603089S, RSL600805S, RSL602369S, RSL601109S, RSL601352S, RSL603441S, RSL601388S, RSL601019S, RSL601562S, RSL602129S, RSL602602S, RSL602610S, RSL602611S, RSL601314S, RSL602614S, RSL602616S, RSL602617S, RSL602618S, RSL602619S, RSL603075S, RSL603077S, RSL603143S, RSL603145S, RSL603494S, RSL603497S, RSL602404S, RSL602405S, RSL602220S, RSL601473S, RSL600963S, RSL602586S, RSL602587S, RSL602122S, RSL602661S, RSL602368S, RSL602378S, RSL602568S, RSL602569S, RSL602573S, RSL602574S, RSL602575S, RSL602576S, RSL602577S, RSL602580S, RSL602581S, RSL602593S, RSL602609S, RSL602634S, RSL602656S, RSL602665S, RSL602787S, RSL602796S, RSL602973S, RSL602983S, RSL602986S, RSL602987S, RSL602989S, RSL603026S, RSL603048S, RSL603082S, RSL603091S, RSL603108S, RSL603124S, RSL603127S, RSL603141S, RSL603146S, RSL603363S, RSL603366S, RSL603367S, RSL603371S, RSL603398S, RSL603405S, RSL603409S, RSL603434S, RSL603435S, RSL603447S, RSL603473S, RSL603479S, RSL603480S, RSL603483S, RSL603486S, RSL603517S, RSL603526S, RSL603537S, RSL603544S, RSL603549S, RSL603550S, RSL603556S, RSL603586S, RSL603594S, RSL603813S, RSL601922S, RSL602024S, RSL602087S, RSL602088S, RSL602113S, RSL602022S, RSL602603S, RSL603370S, RSL603476S, RSL603542S; GTIN 00763000380366, Lot Numbers: RSL600852S, RSL601395S, RSL600476S, RSL600942S, RSL601205S, RSL601247S, RSL602140S, RSL602326S, RSL602646S, RSL603399S, RSL603506S, RSL603528S, RSL603530S, RSL602094S, RSL603787S, RSL600144S, RSL602668S, RSL600775S, RSL600885S, RSL602325S, RSL603350S, RSL600841S, RSL600969S, RSL601575S, RSL602945S, RSL601073S, RSL602361S, RSL603499S, RSL602146S, RSL602947S, RSL603348S, RSL600774S, RSL600890S, RSL603345S, RSL602384S, RSL602387S, RSL602727S, RSL603037S, RSL603043S, RSL603324S, RSL603511S, RSL603044S, RSL603325S, RSL603512S, RSL603470S, RSL600731S, RSL600748S, RSL600899S, RSL600941S, RSL601252S, RSL601396S, RSL602172S, RSL603028S, RSL603054S, RSL602123S, RSL602142S, RSL600796S, RSL601221S, RSL602314S, RSL602681S, RSL602965S, RSL603003S, RSL600987S, RSL600867S, RSL600916S, RSL600968S, RSL601879S, RSL602138S, RSL602954S, RSL603351S, RSL602209S, RSL600925S, RSL600960S, RSL602203S, RSL603335S, RSL600734S, RSL602386S, RSL602722S, RSL602348S, RSL602964S, RSL600980S, RSL602397S, RSL602653S, RSL600991S, RSL602645S, RSL603307S, RSL602278S, RSL603336S, RSL603553S, RSL602373S, RSL603484S, RSL603554S, RSL601286S, RSL601316S, RSL602394S, RSL600792S, RSL601227S, RSL602943S, RSL600902S, RSL601557S, RSL600760S, RSL600931S, RSL601189S, RSL602950S, RSL602401S, RSL603331S, RSL600908S, RSL601890S, RSL603458S, RSL602720S, RSL603332S, RSL603375S, RSL600983S, RSL602284S, RSL600834S, RSL600953S, RSL600864S, RSL603119S, RSL603329S, RSL600897S, RSL600927S, RSL600994S, RSL600995S, RSL601391S, RSL602629S, RSL600977S, RSL601893S, RSL600923S, RSL601923S, RSL602100S, RSL602366S, RSL602385S, RSL603323S, RSL602679S, RSL600898S, RSL601553S, RSL600936S, RSL600937S, RSL600837S, RSL600933S, RSL601550S, RSL601556S, RSL602363S, RSL603340S, RSL602149S, RSL603356S, RSL602644S, RSL600851S, RSL600900S, RSL600928S, RSL600965S, RSL601285S, RSL602658S, RSL602662S, RSL601254S, RSL603327S, RSL603812S, RSL601551S, RSL601883S, RSL602655S, RSL602949S, RSL603310S, RSL600138S, RSL600139S, RSL600982S, RSL600997S, RSL602201S, RSL602642S, RSL602672S, RSL603347S, RSL600128S, RSL602093S, RSL602143S, RSL602154S, RSL602400S, RSL602957S, RSL602331S, RSL602205S, RSL600893S, RSL602402S, RSL602627S, RSL602650S, RSL602654S, RSL602673S, RSL602961S, RSL603485S, RSL600957S, RSL602272S, RSL603450S, RSL602124S, RSL603525S, RSL600872S, RSL601188S, RSL600739S, RSL600926S, RSL601428S, RSL602641S, RSL601884S, RSL602141S, RSL603378S, RSL602282S, RSL602296S, RSL603357S, RSL603353S, RSL600966S, RSL602625S, RSL600886S, RSL602660S, RSL600146S, RSL600752S, RSL600913S, RSL602092S, RSL602135S, RSL602281S, RSL602318S, RSL602330S, RSL602337S, RSL602628S, RSL602674S, RSL602676S, RSL602677S, RSL602981S, RSL603118S, RSL603303S, RSL603313S, RSL603354S, RSL603495S, RSL600742S, RSL600881S, RSL601572S, RSL602160S, RSL601215S, RSL602988S, RSL603465S, RSL601191S, RSL601217S, RSL601411S, RSL603713S, RSL603464S, RSL600134S, RSL600996S, RSL602315S, RSL602350S, RSL603020S, RSL603312S, RSL602948S, RSL602956S, RSL600859S, RSL600862S, RSL602283S, RSL603114S, RSL603474S, RSL600929S, RSL601251S, RSL601328S, RSL601392S, RSL601425S, RSL602270S, RSL602951S, RSL602952S, RSL602969S, RSL603344S, RSL603400S, RSL600946S, RSL601223S, RSL601319S, RSL602145S, RSL602375S, RSL602682S, RSL602683S, RSL602944S, RSL603523S, RSL600737S, RSL600903S, RSL602663S, RSL603016S, RSL603030S, RSL603319S, RSL603462S, RSL600835S, RSL600856S, RSL600950S, RSL601421S, RSL602339S, RSL602391S, RSL602392S, RSL602597S, RSL602967S, RSL603070S, RSL603318S, RSL603320S, RSL603482S, RSL602316S, RSL600962S, RSL601886S, RSL602153S, RSL602338S, RSL603496S, RSL600865S, RSL600914S, RSL600956S, RSL601426S, RSL601593S, RSL601894S, RSL602155S, RSL602396S, RSL603042S, RSL600909S, RSL603027S, RSL603374S, RSL601424S, RSL603115S, RSL601394S, RSL603343S, RSL600883S, RSL600735S, RSL600738S, RSL600132S, RSL603342S, RSL600907S, RSL602147S, RSL603532S, RSL601230S, RSL602667S, RSL602133S, RSL600947S, RSL601228S, RSL602389S, RSL603330S, RSL600924S, RSL601417S, RSL600786S, RSL601201S, RSL603514S, RSL601222S, RSL601880S, RSL602273S, RSL602942S, RSL603317S, RSL602940S, RSL601244S, RSL600861S, RSL600971S, RSL602150S, RSL602310S, RSL603481S, RSL600135S, RSL602095S, RSL603534S, RSL602008S, RSL602364S, RSL600984S, RSL603498S, RSL600791S, RSL602125S, RSL602953S, RSL602332S, RSL600756S, RSL600912S, RSL600921S, RSL601418S, RSL600127S, RSL601926S, RSL603106S, RSL603060S, RSL603314S, RSL603376S, RSL602669S, RSL600973S, RSL602156S, RSL602208S, RSL602323S, RSL600986S, RSL601326S, RSL600131S, RSL600853S, RSL600992S, RSL601888S, RSL602132S, RSL600784S, RSL600783S, RSL600839S, RSL601200S, RSL602121S, RSL600911S, RSL600740S, RSL600967S, RSL600880S, RSL601909S, RSL602319S, RSL602626S, RSL603503S, RSL600978S, RSL602351S, RSL600140S, RSL600750S, RSL600849S, RSL600989S, RSL602126S, RSL602309S, RSL602968S, RSL603322S, RSL603504S, RSL602151S, RSL603000S, RSL600944S, RSL602280S, RSL600136S, RSL602300S, RSL602358S, RSL603341S, RSL600325S, RSL600918S, RSL600920S, RSL601292S, RSL601414S, RSL601415S, RSL601547S, RSL601897S, RSL602137S, RSL602320S, RSL602362S, RSL602594S, RSL602638S, RSL602730S, RSL602946S, RSL603064S, RSL603299S, RSL600768S, RSL600961S, RSL600892S, RSL600137S, RSL601891S, RSL602958S, RSL601592S, RSL602671S, RSL603487S, RSL600767S, RSL602398S, RSL603460S, RSL600773S, RSL600831S, RSL602313S, RSL603008S, RSL603013S, RSL603297S, RSL603522S, RSL602106S, RSL600877S, RSL602287S, RSL603346S, RSL602639S, RSL601558S, RSL602148S, RSL600732S, RSL601892S, RSL602395S, RSL603415S, RSL600866S, RSL602136S, RSL602630S, RSL602637S, RSL600932S, RSL600863S, RSL602657S, RSL600763S, RSL600959S, RSL603001S, RSL600974S, RSL600829S, RSL601291S, RSL600780S, RSL601194S, RSL600832S, RSL601548S, RSL602729S, RSL602960S, RSL600745S, RSL600749S, RSL600895S, RSL600938S, RSL601255S, RSL601422S, RSL602365S, RSL602687S, RSL603298S, RSL603461S, RSL600854S, RSL600143S, RSL600744S, RSL603300S, RSL603543S, RSL601318S, RSL600975S, RSL602139S, RSL603475S, RSL600838S, RSL600887S, RSL602890S, RSL600917S, RSL603339S, RSL600800S, RSL600844S, RSL601243S, RSL601324S, RSL602379S, RSL602966S, RSL602343S, RSL601390S, RSL600889S, RSL601238S, RSL602341S, RSL602342S, RSL602963S, RSL602380S, RSL602377S, RSL603539S, RSL601581S, RSL603527S, RSL600776S, RSL600888S, RSL601237S, RSL602381S, RSL601250S, RSL601289S, RSL601590S, RSL600952S, RSL600905S, RSL602279S, RSL603451S, RSL600799S, RSL601288S, RSL602144S, RSL602393S, RSL603337S, RSL603352S, RSL603391S, RSL600145S, RSL600948S, RSL603541S, RSL600847S, RSL600850S, RSL601924S, RSL600830S, RSL603321S, RSL603393S, RSL603396S, RSL603489S, RSL603507S, RSL601918S, RSL602127S, RSL600988S, RSL601903S, RSL602678S, RSL601315S, RSL602307S, RSL602959S, RSL603334S, RSL602298S, RSL602334S, RSL602383S, RSL603379S, RSL602684S, RSL603100S, RSL602301S, RSL600747S, RSL600836S, RSL602390S, RSL600943S, RSL600843S, RSL602367S, RSL600766S, RSL603491S, RSL603493S, RSL603510S, RSL603535S, RSL603831S
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-929-4043
• Manufacturer Reason for Recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
• Quantity in Commerce: 2748 units
• Distribution: US Nationwide - Worldwide Distribution
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LWS; PMAs with Product Code = LWS