Class 2 Device Recall Medtronic EnTrust Escudo D144DRG

• Date Initiated by Firm: June 21, 2018
• Date Posted: July 10, 2018
• Recall Status: Terminated on June 16, 2021
• Recall Number: Z-2421-2018
• Recall Event ID: 80379
• PMA Number: P980016
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: Medtronic EnTrust Escudo D144DRG (OUS distribution); ; Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
• Code Information: Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR611657S PNR611658S PNR611659S PNR611661S PNR611662S PNR611663S PNR611664S PNR611665S PNR611666S PNR611667S PNR611669S PNR611670S PNR611671S PNR611672S PNR611673S PNR611674S PNR611675S PNR611724S PNR611726S PNR611728S PNR611730S PNR611734S PNR611735S PNR611738S PNR611743S PNR611746S PNR611749S PNR611750S PNR611751S PNR611752S PNR611753S PNR611754S PNR611755S PNR611756S PNR611757S PNR611758S PNR611759S PNR611761S PNR611762S PNR611763S PNR611764S PNR611765S PNR611767S PNR611768S PNR611861S PNR611862S PNR611863S PNR611864S PNR611865S PNR611866S PNR611867S PNR611868S PNR611869S PNR611870S PNR611871S PNR611872S PNR611873S PNR611875S PNR611876S PNR611877S PNR611878S PNR611879S PNR611880S PNR611881S PNR611883S PNR611884S PNR611885S PNR611886S PNR611888S PNR611889S PNR611891S PNR611892S PNR611893S PNR611894S PNR611895S PNR611896S PNR611897S PNR611898S PNR611899S PNR611900S PNR611901S PNR611902S PNR611903S PNR611904S PNR611905S PNR611909S PNR611916S PNR611917S PNR611929S PNR611930S PNR611931S PNR611933S PNR611934S PNR611936S PNR611937S PNR611938S PNR611939S PNR611940S PNR611941S PNR611943S PNR611944S PNR611945S PNR611947S PNR611948S PNR611955S PNR611956S PNR611957S PNR611958S PNR611959S PNR611961S PNR611962S PNR611964S PNR611978S PNR611979S PNR611980S PNR611981S PNR611982S PNR611983S PNR611984S PNR611985S PNR611986S PNR611987S PNR611988S PNR611989S PNR611990S PNR611991S PNR611992S PNR611994S PNR611995S PNR611997S PNR611998S PNR611999S PNR612000S PNR612003S PNR612004S PNR612005S PNR612006S PNR612007S PNR612008S PNR612009S PNR612010S PNR612011S PNR612012S PNR612013S PNR612014S PNR612015S PNR612016S PNR612017S PNR612018S PNR612019S PNR612020S PNR612021S PNR612022S PNR612023S PNR612024S PNR612025S PNR612026S PNR612027S PNR612028S PNR612029S PNR612030S PNR612031S PNR612032S PNR612033S PNR612034S PNR612036S PNR612037S PNR612038S PNR612039S PNR612040S PNR612042S PNR612043S PNR612044S PNR612045S PNR612047S PNR612048S PNR612050S PNR612051S PNR612052S PNR612053S PNR612054S PNR612055S PNR612056S PNR612057S PNR612058S PNR612059S PNR612060S PNR612061S PNR612062S PNR612063S PNR612064S PNR612065S PNR612066S PNR612067S PNR612068S PNR612073S PNR612075S PNR612076S PNR612077S PNR612078S PNR612079S PNR612080S PNR612081S PNR612082S PNR612083S PNR612084S PNR612085S PNR612086S PNR612087S PNR612089S PNR612090S PNR612092S PNR612093S PNR612094S PNR612095S PNR612096S PNR612097S PNR612098S PNR612099S PNR612100S PNR612101S PNR612102S PNR612103S PNR612104S PNR612105S PNR612106S PNR612107S PNR612108S PNR612109S PNR612110S PNR612111S PNR612112S PNR612113S PNR612114S PNR612115S PNR612116S PNR612117S PNR612118S PNR612119S PNR612120S PNR612121S PNR612122S PNR612123S PNR612124S PNR612125S PNR612126S PNR612127S PNR612128S PNR612129S PNR612131S PNR612132S PNR612133S PNR612134S PNR612135S PNR612136S PNR612140S PNR612141S PNR612171S PNR612173S PNR612178S PNR612180S PNR612182S PNR612188S PNR612247S PNR612252S PNR612255S PNR612424S PNR612425S PNR612427S PNR612607S PNR612608S PNR612609S PNR612610S PNR612611S PNR612612S PNR612613S PNR612614S PNR612615S PNR612616S PNR612617S PNR612618S PNR612619S PNR612620S PNR612621S PNR612799S PNR612800S PNR612801S PNR612802S PNR612803S PNR612805S PNR612806S PNR612807S PNR612808S PNR612809S PNR612810S PNR612811S PNR612812S PNR612813S PNR612814S PNR612815S PNR612816S PNR612817S PNR612818S PNR612824S PNR612825S PNR612826S PNR612827S PNR612828S PNR612829S PNR612830S PNR612831S PNR612832S PNR612834S PNR612836S PNR612837S PNR612838S PNR612839S PNR612840S PNR612841S PNR612842S PNR612844S PNR612846S PNR612847S PNR612848S PNR612849S PNR612850S PNR612851S PNR612852S PNR612865S PNR612866S PNR612867S PNR612868S PNR612869S PNR612870S PNR612871S PNR612872S PNR612873S PNR612874S PNR612876S PNR612877S PNR612878S PNR612879S PNR612905S PNR612907S PNR612908S PNR612944S PNR612945S PNR612947S PNR612948S PNR612949S PNR612950S PNR612952S PNR612953S PNR612954S PNR612956S PNR612957S PNR612958S PNR612959S PNR612960S PNR612961S PNR612962S PNR612963S PNR612964S PNR612965S PNR612966S PNR612967S PNR612968S PNR612969S PNR612970S PNR612971S PNR612972S PNR612973S PNR612974S PNR612975S PNR612976S PNR612977S PNR612978S PNR612979S PNR612985S PNR612986S PNR612987S PNR612989S PNR612991S PNR613004S PNR613006S PNR613011S PNR613013S PNR613015S PNR613016S PNR613018S PNR613020S PNR613022S PNR613023S PNR613024S PNR613025S PNR613026S PNR613072S PNR613073S PNR613074S PNR613075S PNR613077S PNR613078S PNR613079S PNR613080S PNR613081S PNR613082S PNR613083S PNR613084S PNR613085S PNR613086S PNR613117S PNR613118S PNR613125S PNR613126S PNR613127S PNR613128S PNR613129S PNR613130S PNR613131S PNR613132S PNR613134S PNR613135S PNR613136S PNR613138S PNR613140S PNR613142S PNR613143S PNR613144S PNR613145S PNR613147S PNR613188S PNR613189S PNR613190S PNR613191S PNR613192S PNR613193S PNR613194S PNR613195S PNR613196S PNR613197S PNR613198S PNR613199S PNR613200S PNR613201S PNR613202S PNR613203S PNR613205S PNR613206S PNR613207S PNR613211S PNR613212S PNR613213S PNR613215S PNR613216S PNR613217S PNR613218S PNR613219S PNR613221S PNR613222S PNR613223S PNR613225S PNR613226S PNR613227S PNR613228S PNR613230S PNR613231S PNR613233S PNR613234S PNR613235S PNR613237S PNR613238S PNR613239S PNR613240S PNR613241S PNR613242S PNR613243S PNR613244S PNR613245S PNR613247S PNR613248S PNR613249S PNR613250S PNR613251S PNR613252S PNR613253S PNR613254S PNR613255S PNR613256S PNR613257S PNR613258S PNR613259S PNR613273S PNR613275S PNR613277S PNR613282S PNR613288S PNR613290S PNR613297S PNR613298S PNR613299S PNR613300S PNR613301S PNR613302S PNR613303S PNR613304S PNR613305S PNR613306S PNR613307S PNR613308S PNR613309S PNR613310S PNR613311S PNR613312S PNR613313S PNR613314S PNR613315S PNR613316S PNR613317S PNR613318S PNR613319S PNR613320S PNR613321S PNR613322S PNR613323S PNR613325S PNR613326S PNR613327S PNR613329S PNR613330S PNR613331S PNR613332S PNR613333S PNR613334S PNR613335S PNR613336S PNR613337S PNR613338S PNR613339S PNR613340S PNR613341S PNR613342S PNR613343S PNR613344S PNR613345S PNR613346S PNR613347S PNR613348S PNR613349S PNR613350S PNR613351S PNR613352S PNR613353S PNR613354S PNR613355S PNR613356S PNR613357S PNR613358S PNR613359S PNR613360S PNR613361S PNR613363S PNR613364S PNR613365S PNR613366S PNR613367S PNR613368S PNR613369S PNR613370S PNR613371S PNR613372S PNR613373S PNR613374S PNR613375S PNR613376S PNR613377S PNR613379S PNR613380S PNR613381S PNR613382S PNR613383S PNR613384S PNR613385S PNR613386S PNR613387S PNR613388S PNR613389S PNR613390S PNR613391S PNR613392S PNR613394S PNR613395S PNR613396S PNR613397S PNR613398S PNR613399S PNR613400S PNR613401S PNR613402S PNR613403S PNR613404S PNR613405S PNR613406S PNR613407S PNR613408S PNR613410S PNR613411S PNR613412S PNR613413S PNR613414S PNR613415S PNR613416S PNR613417S PNR613418S PNR613419S PNR613420S PNR613421S PNR613422S PNR613423S PNR613424S PNR613425S PNR613426S PNR613427S PNR613428S PNR613429S PNR613430S PNR613431S PNR613432S PNR613433S PNR613434S PNR613435S PNR613436S PNR613437S PNR613438S PNR613439S PNR613441S PNR613442S PNR613443S PNR613444S PNR613445S PNR613446S PNR613447S PNR613449S PNR613450S PNR613451S PNR613452S PNR613453S PNR613454S PNR613455S PNR613456S PNR613457S PNR613458S PNR613459S PNR613460S PNR613461S PNR613462S PNR613463S PNR613464S PNR613465S PNR613466S PNR613467S PNR613468S PNR613470S PNR613471S PNR613472S PNR613473S PNR613474S PNR613475S PNR613477S PNR613478S PNR613479S PNR613480S PNR613481S PNR613482S PNR613483S PNR613484S PNR613485S PNR613486S PNR613487S PNR613488S PNR613489S PNR613490S PNR613491S PNR613492S PNR613493S PNR613494S PNR613495S PNR613496S PNR613497S PNR613498S PNR613499S PNR613500S PNR613501S PNR613502S PNR613503S PNR613504S PNR613505S PNR613506S PNR613507S PNR613508S PNR613509S PNR613510S PNR613511S PNR613512S PNR613513S PNR613514S PNR613515S PNR613516S PNR613517S PNR613518S PNR613519S PNR613520S PNR613521S PNR613522S PNR613523S PNR613524S PNR613525S PNR613526S PNR613527S PNR613528S PNR613530S PNR613531S PNR613532S PNR613533S PNR613534S PNR613535S PNR613536S PNR613537S PNR613538S PNR613539S PNR613540S PNR613541S PNR613542S PNR613543S PNR613544S PNR613545S PNR613546S PNR613547S PNR613548S PNR613549S PNR613550S PNR613551S PNR613553S PNR613554S PNR613555S PNR613556S PNR613557S PNR613558S PNR613559S PNR613560S PNR613561S PNR613562S PNR613563S PNR613564S PNR613565S PNR613566S PNR613567S PNR613568S PNR613569S PNR613570S PNR613571S PNR613572S PNR613573S PNR613574S PNR613575S PNR613576S PNR613578S PNR613579S PNR613580S PNR613581S PNR613582S PNR613583S PNR613584S PNR613585S PNR613586S PNR613587S PNR613588S PNR613589S PNR613602S PNR613603S PNR613604S PNR613606S PNR613607S PNR613608S PNR613609S PNR613610S PNR613611S PNR613612S PNR613613S PNR613614S PNR613615S PNR613616S PNR613617S PNR613618S PNR613619S PNR613620S PNR613621S PNR613622S PNR613623S PNR613624S PNR613625S PNR613627S PNR613628S PNR613630S PNR613631S PNR613632S PNR613633S PNR613634S PNR613635S PNR613636S PNR613637S PNR613638S PNR613639S PNR613640S PNR613641S PNR613642S PNR613643S PNR613644S PNR613645S PNR613646S PNR613647S PNR613648S PNR613649S PNR613650S PNR613651S PNR613652S PNR613653S PNR613654S PNR613655S PNR613656S PNR613657S PNR613658S PNR613659S PNR613660S PNR613661S PNR613662S PNR613663S PNR613664S PNR613665S PNR613666S PNR613667S PNR613668S PNR613669S PNR613670S PNR613671S PNR613672S PNR613673S PNR613674S PNR613675S PNR613676S PNR613677S PNR613678S PNR613681S PNR613682S PNR613683S PNR613684S PNR613685S PNR613686S PNR613687S PNR613688S PNR613689S PNR613691S PNR613692S PNR613693S PNR613695S PNR613696S PNR613697S PNR613698S PNR613699S PNR613700S PNR613701S PNR613702S PNR613703S PNR613704S PNR613705S PNR613706S PNR613707S PNR613708S PNR613710S PNR613711S PNR613712S PNR613715S PNR613716S PNR613717S PNR613719S PNR613721S PNR613723S PNR613725S PNR613726S PNR613727S PNR613728S PNR613729S PNR613731S PNR613733S PNR613734S PNR613735S PNR613737S PNR613738S PNR613739S PNR613740S PNR613741S PNR613742S PNR613743S PNR613744S PNR613745S PNR613746S PNR613747S PNR613748S PNR613749S PNR613751S PNR613752S PNR613753S PNR613754S PNR613755S PNR613756S PNR613757S PNR613758S PNR613759S PNR613760S PNR613761S PNR613762S PNR613763S PNR613764S PNR613765S PNR613766S PNR613767S PNR613770S PNR613771S PNR613772S PNR613773S PNR613774S PNR613775S PNR613776S PNR613779S PNR613780S PNR613781S PNR613782S PNR613783S PNR613784S PNR613785S PNR613786S PNR613787S PNR613788S PNR613790S PNR613791S PNR613792S PNR613793S PNR613794S PNR613795S PNR613796S PNR613797S PNR613798S PNR613799S PNR613800S PNR613801S PNR613802S PNR613803S PNR613804S PNR613806S PNR613807S PNR613808S PNR613809S PNR613810S PNR613811S PNR613812S PNR613813S PNR613814S PNR613815S PNR613817S PNR613819S PNR613820S PNR613821S PNR613822S PNR613823S PNR613824S PNR613825S PNR613826S PNR613827S PNR613828S PNR613829S PNR613830S PNR613831S PNR613832S PNR613833S PNR613834S PNR613835S PNR613836S PNR613837S PNR613838S PNR613839S PNR613841S PNR613842S PNR613844S PNR613845S PNR613846S PNR613847S PNR613848S PNR613849S PNR613850S PNR613851S PNR613852S PNR613853S PNR613854S PNR613855S PNR613856S PNR613857S PNR613858S PNR613859S PNR613860S PNR613861S PNR613862S PNR613863S PNR613864S PNR613865S PNR613866S PNR613867S PNR613868S PNR613869S PNR613870S PNR613871S PNR613872S PNR613873S PNR613874S PNR613875S PNR613876S PNR613877S PNR613878S PNR613879S PNR613880S PNR613881S PNR613882S PNR613883S PNR613884S PNR613885S PNR613886S PNR613887S PNR613888S PNR613889S PNR613890S PNR613891S PNR613892S PNR613893S PNR613894S PNR613895S PNR613896S PNR613897S PNR613898S PNR613899S PNR613900S PNR613901S PNR613902S PNR613903S PNR613904S PNR613905S PNR613906S PNR613907S PNR613908S PNR613909S PNR613910S PNR613911S PNR613912S PNR613913S PNR613914S PNR613915S PNR613916S PNR613917S PNR613918S PNR613919S PNR613921S PNR613922S PNR613923S PNR613924S PNR613925S PNR613926S PNR613927S PNR613928S PNR613929S PNR613930S PNR613931S PNR613932S PNR613933S PNR613934S PNR613935S PNR613936S PNR613937S PNR613938S PNR613939S PNR613940S PNR613941S PNR613942S PNR613943S PNR613944S PNR613945S PNR613946S PNR613947S PNR613948S PNR613949S PNR613950S PNR613951S PNR613952S PNR613953S PNR613954S PNR613955S PNR613956S PNR613957S PNR613958S PNR613959S PNR613960S PNR613961S PNR613962S PNR613963S PNR613964S PNR613965S PNR613966S PNR613967S PNR613968S PNR613969S PNR613970S PNR613986S PNR613987S PNR613988S PNR613989S PNR613990S PNR613991S PNR613992S PNR613993S PNR613994S PNR613995S PNR613996S PNR613997S PNR613998S PNR613999S PNR614000S PNR614001S PNR614002S PNR614003S PNR614004S PNR614005S PNR614006S PNR614008S PNR614011S PNR614012S PNR614013S PNR614014S PNR614015S PNR614016S PNR614017S PNR614018S PNR614019S PNR614020S PNR614021S PNR614022S PNR614023S PNR614024S PNR614025S PNR614026S PNR614027S PNR614028S PNR614029S PNR614030S PNR614031S PNR614032S PNR614033S PNR614034S PNR614035S PNR614036S PNR614037S PNR614038S PNR614039S PNR614040S PNR614041S PNR614042S PNR614043S PNR614044S PNR614045S PNR614046S PNR614047S PNR614048S PNR614049S PNR614050S PNR614051S PNR614052S PNR614053S PNR614054S PNR614055S PNR614056S PNR614057S PNR614058S PNR614059S PNR614060S PNR614061S PNR614062S PNR614063S PNR614064S PNR614065S PNR614066S PNR614068S PNR614069S PNR614070S PNR614071S PNR614072S PNR614073S PNR614074S PNR614076S PNR614077S PNR614078S PNR614079S PNR614080S PNR614081S PNR614082S PNR614083S PNR614084S PNR614085S PNR614086S PNR614087S PNR614088S PNR614090S PNR614091S PNR614092S PNR614093S PNR614094S PNR614095S PNR614096S PNR614098S PNR614099S PNR614100S PNR614101S PNR614102S PNR614103S PNR614104S PNR614105S PNR614107S PNR614108S PNR614109S PNR614110S PNR614111S PNR614112S PNR614113S PNR614114S PNR614115S PNR614116S PNR614117S PNR614118S PNR614119S PNR614120S PNR614121S PNR614122S PNR614124S PNR614126S PNR614127S PNR614128S PNR614129S PNR614130S PNR614131S PNR614132S PNR614133S PNR614134S PNR614136S PNR614137S PNR614138S PNR614139S PNR614141S PNR614142S PNR614143S PNR614160S PNR614161S PNR614163S PNR614164S PNR614165S PNR614166S PNR614167S PNR614168S PNR614169S PNR614170S PNR614171S PNR614174S PNR614175S PNR614176S PNR614177S PNR614178S PNR614179S PNR614180S PNR614184S PNR614185S PNR614186S PNR614187S PNR614188S PNR614189S PNR614190S PNR614191S PNR614192S PNR614193S PNR614194S PNR614195S PNR614196S PNR614197S PNR614198S PNR614199S PNR614200S PNR614201S PNR614202S PNR614203S PNR614204S PNR614205S PNR614206S PNR614207S PNR614208S PNR614209S PNR614210S PNR614211S PNR614212S PNR614213S PNR614214S PNR614215S PNR614216S PNR614217S PNR614218S PNR614219S PNR614220S PNR614221S PNR614222S PNR614223S PNR614224S PNR614225S PNR614226S PNR614227S PNR614228S PNR614229S PNR614231S PNR614232S PNR614233S PNR614234S PNR614235S PNR614236S PNR614237S PNR614239S PNR614240S PNR614241S PNR614242S PNR614243S PNR614244S PNR614245S PNR614246S PNR614247S PNR614248S PNR614249S PNR614250S PNR614251S PNR614252S PNR614253S PNR614254S PNR614256S PNR614257S PNR614258S PNR614259S PNR614260S PNR614262S PNR614264S PNR614265S PNR614266S PNR614267S PNR614268S PNR614269S PNR614270S PNR614271S PNR614272S PNR614273S PNR614274S PNR614275S PNR614276S PNR614277S PNR614278S PNR614279S PNR614280S PNR614281S PNR614282S PNR614283S PNR614284S PNR614285S PNR614286S PNR614287S PNR614288S PNR614289S PNR614290S PNR614291S PNR614292S PNR614293S PNR614294S PNR614295S PNR614297S PNR614298S PNR614299S PNR614300S PNR614301S PNR614303S PNR614304S PNR614305S PNR614307S PNR614308S PNR614309S PNR614370S PNR614371S PNR614372S PNR614373S PNR614374S PNR614375S PNR614376S PNR614377S PNR614378S PNR614379S PNR614380S PNR614381S PNR614382S PNR614384S PNR614385S PNR614386S PNR614387S PNR614389S PNR614390S PNR614391S PNR614392S PNR614393S PNR614394S PNR614395S PNR614396S PNR614397S PNR614398S PNR614399S PNR614400S PNR614401S PNR614405S PNR614407S PNR614415S PNR614416S PNR614418S PNR614419S PNR614420S PNR614421S PNR614422S PNR614423S PNR614424S PNR614425S PNR614426S PNR614427S PNR614428S PNR614429S PNR614430S PNR614431S PNR614432S PNR614433S PNR614434S PNR614435S PNR614436S PNR614437S PNR614438S PNR614439S PNR614440S PNR614441S PNR614442S PNR614443S PNR614444S PNR614445S PNR614446S PNR614447S PNR614448S PNR614449S PNR614450S PNR614451S PNR614452S PNR614453S PNR614455S PNR614456S PNR614457S PNR614458S PNR614459S PNR614460S PNR614461S PNR614463S PNR614464S PNR614465S PNR614466S PNR614467S PNR614468S PNR614470S PNR614471S PNR614472S PNR614473S PNR614475S PNR614476S PNR614477S PNR614478S PNR614479S PNR614480S PNR614481S PNR614482S PNR614483S PNR614484S PNR614485S PNR614486S PNR614487S PNR614488S PNR614489S PNR614490S PNR614491S PNR614492S PNR614494S PNR614495S PNR614496S PNR614497S PNR614498S PNR614499S PNR614500S PNR614501S PNR614502S PNR614503S PNR614504S PNR614505S PNR614506S PNR614507S PNR614508S PNR614509S PNR614510S PNR614511S PNR614512S PNR614514S PNR614515S PNR614516S PNR614517S PNR614518S PNR614519S PNR614520S PNR614521S PNR614522S PNR614523S PNR614524S PNR614525S PNR614527S PNR614528S PNR614529S PNR614530S PNR614531S PNR614533S PNR614534S PNR614535S PNR614538S PNR614539S PNR614540S PNR614541S PNR614542S PNR614543S PNR614544S PNR614545S PNR614546S PNR614547S PNR614548S PNR614549S PNR614550S PNR614551S PNR614552S PNR614553S PNR614554S PNR614555S PNR614556S PNR614557S PNR614558S PNR614560S PNR614561S PNR614562S PNR614563S PNR614564S PNR614565S PNR614566S PNR614567S PNR614568S PNR614569S PNR614571S PNR614574S PNR614575S PNR614576S PNR614578S PNR614579S PNR614582S PNR614583S PNR614584S PNR614585S PNR614586S PNR614588S PNR614589S PNR614590S PNR614591S PNR614592S PNR614593S PNR614594S PNR614595S PNR614596S PNR614597S PNR614598S PNR614599S PNR614600S PNR614601S PNR614603S PNR614604S PNR614605S PNR614606S PNR614607S PNR614609S PNR614610S PNR614611S PNR614612S PNR614613S PNR614615S PNR614616S PNR614618S PNR614621S PNR614622S PNR614624S PNR614625S PNR614627S PNR614629S PNR614631S PNR614632S PNR614633S PNR614635S PNR614636S PNR614637S PNR614638S PNR614639S PNR614640S PNR614641S PNR614642S PNR614643S PNR614644S PNR614645S PNR614646S PNR614647S PNR614648S PNR614649S PNR614650S PNR614651S PNR614652S PNR614653S PNR614654S PNR614655S PNR614656S PNR614657S PNR614659S PNR614660S PNR614661S PNR614662S PNR614663S PNR614664S PNR614665S PNR614668S PNR614670S PNR614671S PNR614672S PNR614673S PNR614674S PNR614675S PNR614676S PNR614677S PNR614678S PNR614679S PNR614680S PNR614681S PNR614685S PNR614687S PNR614688S PNR614689S PNR614690S PNR614692S PNR614693S PNR614694S PNR614697S PNR614698S PNR614700S PNR614701S PNR614702S PNR614704S PNR614705S PNR614706S PNR614709S PNR614710S PNR614711S PNR614712S PNR614713S PNR614714S PNR614715S PNR614716S PNR614717S PNR614718S PNR614720S PNR614722S PNR614723S PNR614724S PNR614727S PNR614728S PNR614729S PNR614731S PNR614732S PNR614733S PNR614734S PNR614735S PNR614736S PNR614737S PNR614738S PNR614739S PNR614740S PNR614741S PNR614742S PNR614743S PNR614744S PNR614745S PNR614746S PNR614747S PNR614748S PNR614749S PNR614750S PNR614751S PNR614752S PNR614753S PNR614754S PNR614755S PNR614756S PNR614757S PNR614758S PNR614759S PNR614760S PNR614761S PNR614764S PNR614765S PNR614766S PNR614767S PNR614768S PNR614769S PNR614770S PNR614772S PNR614773S PNR614774S PNR614775S PNR614776S PNR614777S PNR614778S PNR614779S PNR614780S PNR614781S PNR614782S PNR614783S PNR614784S PNR614785S PNR614786S PNR614787S PNR614788S PNR614792S PNR614793S PNR614795S PNR614796S PNR614797S PNR614798S PNR614799S PNR614800S PNR614801S PNR614802S PNR614804S PNR614805S PNR614806S PNR614808S PNR614809S PNR614811S PNR614812S PNR614813S PNR614814S PNR614815S PNR614816S PNR614817S PNR614818S PNR614819S PNR614820S PNR614821S PNR614822S PNR614823S PNR614824S PNR614826S PNR614827S PNR614828S PNR614829S PNR614830S PNR614831S PNR614833S PNR614834S PNR614835S PNR614837S PNR614838S PNR614839S PNR614841S PNR614842S PNR614843S PNR614844S PNR614847S PNR614848S PNR614849S PNR614850S PNR614851S PNR614852S PNR614853S PNR614854S PNR614855S PNR614856S PNR614857S PNR614858S PNR614859S PNR614861S PNR614862S PNR614864S PNR614865S PNR614866S PNR614867S PNR614868S PNR614869S PNR614870S PNR614872S PNR614873S PNR614874S PNR614875S PNR614876S PNR614877S PNR614878S PNR614879S PNR614882S PNR614883S PNR614884S PNR614885S PNR614886S PNR614898S PNR614901S PNR614902S PNR614903S PNR614904S PNR614905S PNR614906S PNR614908S PNR614910S PNR614912S PNR614913S PNR614915S PNR614916S PNR614917S PNR614918S PNR614919S PNR614920S PNR614921S PNR614922S PNR614923S PNR614924S PNR614925S PNR614926S PNR614927S PNR614928S PNR614929S PNR614930S PNR614931S PNR614932S PNR615003S
• 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: Medtronic Technical Services; 800-723-4696
• Manufacturer Reason for Recall: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
• FDA Determined Cause: Device Design
• Action: On 21-Jun-2018, Medtronic began notifying US follow-up physicians, and Risk Managers of health care facilities of this issue via hand delivery by Field Representatives. In consultation with an Independent Physician Quality Panel, MDT recommends the physicians following patients with affected devices: " Consider scheduling an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps described below. " Use a programmer to ensure the Excessive Charge Time EOL&and the Low Battery Voltage ERI& Patient Alerts have been programmed to On-High " Instruct patients to contact your office if they hear device alert tones. " If this issue has occurred, an EOL: replace device immediately Observation will be displayed on the programmer QuickLook report. Schedule device replacement immediately. The notification provided Patient Management recommendations to ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61V ERI threshold.
• Quantity in Commerce: 1867 units
• Distribution: Worldwide Distribution - US Nationwide
• Total Product Life Cycle: TPLC Device Report

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

• PMA Database: PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.