Class 2 Device Recall Medtronic, Consulta CRTP, Syncra CRTP

• Date Initiated by Firm: June 07, 2013
• Date Posted: June 27, 2013
• Recall Status: Terminated on March 07, 2014
• Recall Number: Z-1607-2013
• Recall Event ID: 65433
• PMA Number: P010015S084
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. ; ; Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
• Code Information: UPDATED 7/18/2013: Serial Numbers: PVX610233S, PVX610234S, PVX610253S, PVX610258S, PVX610296S, PVX610302S, PVX610308S, PVX610311S, PVX610312S, PVX610313S, PVX610314S, PVX610315S, PVX610317S, PVX610318S, PVX610319S, PVX610320S, PVX610321S, PVX610323S, PVX610324S, PVX610325S, PVX610326S, PVX610328S, PVX610329S, PVX610331S, PVX610332S, PVX610334S, PVX610335S, PVX610337S, PVX610338S, PVX610339S, PVX610340S, PVX610341S, PVX610342S, PVX610343S, PVX610344S, PVX610346S, PVX610347S, PVX610348S, PVX610350S, PVX610352S, PVX610353S, PVX610355S, PVX610358S, PVX610360S, PVX610361S, PVX610364S, PVX610366S, PVX610367S, PVX610368S, PVX610371S, PVX610372S, PVX610373S, PVX610374S, PVX610375S, PVX610376S, PVX610377S, PVX610378S, PVX610379S, PVX610380S, PVX610381S, PVX610382S, PVX610383S, PVX610384S, PVX610385S, PVX610386S, PVX610387S, PVX610388S, PVX610389S, PVX610390S, PVX610391S, PVX610392S, PVX610393S, PVX610395S, PVX610396S, PVX610397S, PVX610398S, PVX610399S, PVX610400S, PVX610401S, PVX610403S, PVX610405S, PVX610407S, PVX610408S, PVX610409S, PVX610410S, PVX610411S, PVX610414S, PVX610415S, PVX610418S, PVX610420S, PVX610421S, PVX610425S, PVX610426S, PVX610428S, PVX610429S, PVX610435S, PVX610443S, PVX610444S, PVX610445S, PVX610446S, PVX610449S, PVX610450S, PVX610452S, PVX610455S, PVX610457S, PVX610458S, PVX610459S, PVX610461S, PVX610462S, PVX610465S, PVX610467S, PVX610468S, PVX610470S, PVX610473S, PVX610474S, PVX610475S, PVX610480S, PVX610481S, PVX610482S, PVX610485S, PVX610489S, PVX610494S, PVX610498S, PVX610501S, PVX610502S, PVX610509S, PVX610510S, PVX610514S, PVX610522S, PVX610523S, PVX610524S, PVX610525S, PVX610526S, PVX610527S, PVX610528S, PVX610529S, PVX610535S, PVX610543S, PVX610589S, PVX610607S, PVX610642S, PVX610644S, PVX610671S, PVX610698S, PVX610732S, PVX610742S, PVX610764S, PVX610797S, PVX610809S, PVX610817S, PVX610822S, PVX610824S, PVX610826S, PVX610828S, PVX610840S, PVX610843S, PVX610844S, PVX610845S, PVX610848S, PVX610852S, PVX610853S, PVX610855S, PVX610856S, PVX610857S, PVX610858S, PVX610859S, PVX610860S, PVX610861S, PVX610862S, PVX610863S, PVX610865S, PVX610866S, PVX610867S, PVX610868S, PVX610869S, PVX610870S, PVX610871S, PVX610872S, PVX610873S, PVX610874S, PVX610875S, PVX610876S, PVX610878S, PVX610879S, PVX610880S, PVX610881S, PVX610884S, PVX610889S, PVX610891S, PVX610892S, PZI614616S, PZI614617S, PZI614618S, PZI614619S, PZI614620S, PZI614621S, PZI614622S, PZI614623S, PZI614624S, PZI614625S, PZI614626S, PZI614627S, PZI614628S, PZI614629S, PZI614630S, PZI614631S, PZI614632S, PZI614633S, PZI614634S, PZI614635S, PZI614636S, PZI614637S, PZI614638S, PZI614639S, PZI614640S, PZI614641S, PZI614642S, PZI614643S, PZI614644S, PZI614645S, PZI614646S, PZI614647S, PZI614648S, PZI614656S, PZI614657S, PZI614658S, PZI614659S, PZI614660S, PZI614661S, PZI614662S, PZI614663S, PZI614664S, PZI614665S, PZI614666S, PZI614667S, PZI614668S, PZI614669S, PZI614670S, PZI614671S, PZI614672S, PZI614673S, PZI614674S, PZI614675S, PZI614676S, PZI614677S, PZI614678S, PZI614679S, PZI614680S, PZI614681S, PZI614682S, PZI614683S, PZI614684S, PZI614686S, PZI614687S, PZI614688S, PZI614689S, PZI614690S, PZI614691S, PZI614693S, PZI614694S, PZI614695S, PZI614696S, PZI614697S, PZI614698S, PZI614699S, PZI614700S, PZI614701S, PZI614702S, PZI614703S, PZI614704S, PZI614705S, PZI614706S, PZI614707S, PZI614708S, PZI614710S, PZI614711S, PZI614712S, PZI614713S, PZI614714S, PZI614715S, PZI614716S, PZI614717S, PZI614718S, PZI614720S, PZI614721S, PZI614722S, PZI614723S, PZI614724S, PZI614725S, PZI614726S, PZI614727S, PZI614728S, PZI614729S, PZI614730S, PZI614731S, PZI614732S, PZI614733S, PZI614734S, PZI614736S, PZI614737S, PZI614738S, PZI614739S, PZI614740S, PZI614741S, PZI614742S, PZI614743S, PZI614744S, PZI614745S, PZI614746S, PZI614747S, PZI614748S, PZI614749S, PZI614750S, PZI614751S, PZI614752S, PZI614753S, PZI614754S, PZI614755S, PZI614756S, PZI614757S, PZI614759S, PZI614760S, PZI614761S, PZI614762S, PZI614763S, PZI614764S, PZI614765S, PZI614767S, PZI614768S, PZI614769S, PZI614770S, PZI614771S, PZI614772S, PZI614773S, PZI614774S, PZI614775S, PZI614776S, PZI614777S, PZI614779S, PZI614780S, PZI614781S, PZI614782S, PZI614783S, PZI614784S, PZI614785S, PZI614786S, PZI614787S, PZI614789S, PZI614790S, PZI614791S, PZI614792S, PZI614794S, PZI614795S, PZI614796S, PZI614797S, PZI614798S, PZI614799S, PZI614800S, PZI614801S, PZI614802S, PZI614803S, PZI614804S, PZI614805S, PZI614806S, PZI614807S, PZI614808S, PZI614809S, PZI614810S, PZI614811S, PZI614812S, PZI614813S, PZI614814S, PZI614815S, PZI614817S, PZI614818S, PZI614819S, PZI614820S, PZI614821S, PZI614822S, PZI614823S, PZI614824S, PZI614825S, PZI614826S, PZI614827S, PZI614828S, PZI614831S, PZI614832S, PZI614833S, PZI614834S, PZI614835S, PZI614836S, PZI614837S, PZI614838S, PZI614839S, PZI614840S, PZI614841S, PZI614842S, PZI614843S, PZI614844S, PZI614845S, PZI614846S, PZI614847S, PZI614848S, PZI614849S, PZI614850S, PZI614851S, PZI614852S, PZI614853S, PZI614854S, PZI614855S, PZI614856S, PZI614857S, PZI614859S, PZI614860S, PZI614861S, PZI614862S, PZI614863S, PZI614864S, PZI614865S, PZI614866S, PZI614867S, PZI614868S, PZI614869S, PZI614870S, PZI614871S, PZI614872S, PZI614875S, PZI614876S, PZI614877S, PZI614878S, PZI614879S, PZI614880S, PZI614881S, PZI614882S, PZI614883S, PZI614884S, PZI614885S, PZI614886S, PZI614887S, PZI614888S, PZI614889S, PZI614890S, PZI614891S, PZI614892S, PZI614893S, PZI614895S, PZI614896S, PZI614897S, PZI614898S, PZI614899S, PZI614900S, PZI614901S, PZI614903S, PZI614904S, PZI614905S, PZI614906S, PZI614907S, PZI614908S, PZI614909S, PZI614910S, PZI614911S, PZI614912S, PZI614913S, PZI614914S, PZI614915S, PZI614916S, PZI614917S, PZI614918S, PZI614919S, PZI614922S, PZI614923S, PZI614924S, PZI614926S, PZI614927S, PZI614928S, PZI614929S, PZI614930S, PZI614931S, PZI614932S, PZI614933S, PZI614935S, PZI614936S, PZI614937S, PZI614939S, PZI614940S, PZI614941S, PZI614943S, PZI614944S, PZI614945S, PZI614946S, PZI614947S, PZI614949S, PZI614951S, PZI614952S, PZI614953S, PZI614954S, PZI614955S, PZI614956S, PZI614957S, PZI614958S, PZI614959S, PZI614960S, PZI614961S, PZI614962S, PZI614963S, PZI614964S, PZI614965S, PZI614966S, PZI614967S, PZI614968S, PZI614969S, PZI614970S, PZI614971S, PZI614972S, PZI614973S, PZI614974S, PZI614975S, PZI614976S, PZI614977S, PZI614978S, PZI614979S, PZI614980S, PZI614981S, PZI614982S, PZI614983S, PZI614984S, PZI614985S, PZI614986S, PZI614987S, PZI614988S, PZI614989S, PZI614990S, PZI614992S, PZI614993S, PZI614995S, PZI614996S, PZI614997S, PZI614999S, PZI615000S, PZI615002S, PZI615003S, PZI615004S, PZI615005S, PZI615006S, PZI615007S, PZI615008S, PZI615009S, PZI615010S, PZI615011S, PZI615012S, PZI615013S, PZI615014S, PZI615015S, PZI615016S, PZI615018S, PZI615019S, PZI615022S, PZI615023S, PZI615024S, PZI615025S, PZI615026S, PZI615027S, PZI615030S, PZI615032S, PZI615033S, PZI615034S, PZI615039S, PZI615040S, PZI615042S, PZI615043S, PZI615046S, PZI615047S, PZI615048S, PZI615052S, PZI615053S, PZI615054S, PZI615055S, PZI615056S, PZI615057S, PZI615059S, PZI615061S, PZI615062S, PZI615064S, PZI615065S, PZI615066S, PZI615067S, PZI615068S, PZI615072S, PZI615076S, PZI615077S, PZI615078S, PZI615079S, PZI615080S, PZI615081S, PZI615082S, PZI615083S, PZI615085S, PZI615086S, PZI615087S, PZI615088S, PZI615089S, PZI615091S, PZI615095S, PZI615097S, PZI615098S, PZI615099S, PZI615100S, PZI615101S, PZI615102S, PZI615103S, PZI615104S, PZI615105S, PZI615107S, PZI615108S, PZI615109S, PZI615111S, PZI615112S, PZI615117S, PZI615120S, PZI615121S, PZI615123S, PZI615124S, PZI615125S, PZI615126S, PZI615127S, PZI615129S, PZI615131S, PZI615133S, PZI615134S, PZI615135S, PZI615148S, PZI615172S, PZI615176S, PZI615185S, PZI615186S, PZI615188S, PZI615191S, PZI615192S, PZX624804S, PZX625573S, PZX626117S, PZX626118S, PZX626136S, PZX626137S, PZX626138S, PZX626139S, PZX626140S, PZX626141S, PZX626142S, PZX626143S, PZX626144S, PZX626145S, PZX626146S, PZX626147S, PZX626148S, PZX626149S, PZX626150S, PZX626151S, PZX626152S, PZX626153S, PZX626154S, PZX626155S, PZX626156S, PZX626157S, PZX626158S, PZX626159S, PZX626160S, PZX626161S, PZX626162S, PZX626163S, PZX626164S, PZX626165S, PZX626166S, PZX626167S, PZX626168S, PZX626169S, PZX626170S, PZX626171S, PZX626172S, PZX626173S, PZX626174S, PZX626175S, PZX626176S, PZX626177S, PZX626178S, PZX626179S, PZX626180S, PZX626181S, PZX626182S, PZX626183S, PZX626184S, PZX626185S, PZX626186S, PZX626187S, PZX626188S, PZX626189S, PZX626190S, PZX626191S, PZX626192S, PZX626193S, PZX626194S, PZX626195S, PZX626196S, PZX626197S, PZX626198S, PZX626199S, PZX626200S, PZX626201S, PZX626202S, PZX626203S, PZX626204S, PZX626205S, PZX626206S, PZX626207S, PZX626208S, PZX626209S, PZX626210S, PZX626211S, PZX626212S, PZX626213S, PZX626214S, PZX626215S, PZX626216S, PZX626217S, PZX626218S, PZX626219S, PZX626220S, PZX626221S, PZX626222S, PZX626223S, PZX626224S, PZX626225S, PZX626226S, PZX626227S, PZX626228S, PZX626229S, PZX626230S, PZX626231S, PZX626232S, PZX626233S, PZX626234S, PZX626235S, PZX626236S, PZX626237S, PZX626238S, PZX626239S, PZX626240S, PZX626241S, PZX626242S, PZX626243S, PZX626244S, PZX626245S, PZX626246S, PZX626247S, PZX626248S, PZX626249S, PZX626250S, PZX626251S, PZX626252S, PZX626253S, PZX626254S, PZX626255S, PZX626256S, PZX626257S, PZX626258S, PZX626259S, PZX626260S, PZX626261S, PZX626262S, PZX626263S, PZX626264S, PZX626265S, PZX626266S, PZX626267S, PZX626268S, PZX626269S, PZX626270S, PZX626271S, PZX626272S, PZX626273S, PZX626274S, PZX626275S, PZX626276S, PZX626277S, PZX626278S, PZX626279S, PZX626280S, PZX626281S, PZX626282S, PZX626283S, PZX626285S, PZX626286S, PZX626287S, PZX626288S, PZX626289S, PZX626290S, PZX626291S, PZX626292S, PZX626294S, PZX626296S, PZX626297S, PZX626298S, PZX626299S, PZX626300S, PZX626301S, PZX626302S, PZX626303S, PZX626304S, PZX626305S, PZX626306S, PZX626307S, PZX626308S, PZX626309S, PZX626310S, PZX626311S, PZX626312S, PZX626313S, PZX626318S, PZX626319S, PZX626320S, PZX626321S, PZX626322S, PZX626323S, PZX626324S, PZX626325S, PZX626326S, PZX626327S, PZX626328S, PZX626329S, PZX626330S, PZX626331S, PZX626333S, PZX626334S, PZX626335S, PZX626336S, PZX626337S, PZX626338S, PZX626340S, PZX626341S, PZX626342S, PZX626343S, PZX626344S, PZX626345S, PZX626346S, PZX626347S, PZX626348S, PZX626349S, PZX626350S, PZX626351S, PZX626352S, PZX626353S, PZX626354S, PZX626355S, PZX626356S, PZX626357S, PZX626358S, PZX626359S, PZX626360S, PZX626361S, PZX626362S, PZX626364S, PZX626365S, PZX626367S, PZX626368S, PZX626369S, PZX626370S, PZX626371S, PZX626372S, PZX626373S, PZX626374S, PZX626375S, PZX626376S, PZX626377S, PZX626378S, PZX626379S, PZX626380S, PZX626381S, PZX626382S, PZX626383S, PZX626384S, PZX626385S, PZX626386S, PZX626387S, PZX626388S, PZX626389S, PZX626390S, PZX626391S, PZX626392S, PZX626393S, PZX626394S, PZX626395S, PZX626396S, PZX626397S, PZX626398S, PZX626399S, PZX626400S, PZX626401S, PZX626402S, PZX626403S, PZX626404S, PZX626405S, PZX626406S, PZX626407S, PZX626408S, PZX626409S, PZX626410S, PZX626411S, PZX626412S, PZX626413S, PZX626414S, PZX626415S, PZX626416S, PZX626417S, PZX626418S, PZX626419S, PZX626420S, PZX626421S, PZX626422S, PZX626423S, PZX626424S, PZX626425S, PZX626426S, PZX626427S, PZX626428S, PZX626429S, PZX626430S, PZX626431S, PZX626432S, PZX626433S, PZX626434S, PZX626435S, PZX626436S, PZX626437S, PZX626438S, PZX626439S, PZX626440S, PZX626441S, PZX626442S, PZX626443S, PZX626444S, PZX626445S, PZX626446S, PZX626447S, PZX626448S, PZX626449S, PZX626450S, PZX626452S, PZX626453S, PZX626454S, PZX626455S, PZX626456S, PZX626457S, PZX626458S, PZX626459S, PZX626460S, PZX626461S, PZX626462S, PZX626463S, PZX626465S, PZX626466S, PZX626467S, PZX626468S, PZX626469S, PZX626470S, PZX626471S, PZX626472S, PZX626473S, PZX626474S, PZX626475S, PZX626476S, PZX626477S, PZX626478S, PZX626479S, PZX626480S, PZX626481S, PZX626482S, PZX626483S, PZX626484S, PZX626485S, PZX626486S, PZX626487S, PZX626488S, PZX626489S, PZX626490S, PZX626491S, PZX626492S, PZX626493S, PZX626494S, PZX626495S, PZX626496S, PZX626497S, PZX626498S, PZX626499S, PZX626500S, PZX626501S, PZX626502S, PZX626503S, PZX626504S, PZX626505S, PZX626506S, PZX626507S, PZX626512S, PZX626519S, PZX626520S, PZX626521S, PZX626522S, PZX626542S, PZX626543S, PZX626571S, PZX626574S, PZX626575S, PZX626584S, PZX626586S, PZX626596S, PZX626604S, PZX626606S, PZX626608S, PZX626619S, PZX626621S, PZX626625S, PZX626631S, PZX626635S, PZX626643S, PZX626658S, PZX626659S, PZX626669S, PZX626671S, PZX626674S, PZX626677S, PZX626691S, PZX626696S, PZX626697S, PZX626698S, PZX626699S, PZX626700S, PZX626701S, PZX626702S, PZX626703S, PZX626704S, PZX626705S, PZX626706S, PZX626707S, PZX626708S, PZX626709S, PZX626710S, PZX626711S, PZX626712S, PZX626715S, PZX626716S, PZX626717S, PZX626718S, PZX626719S, PZX626721S, PZX626723S, PZX626724S, PZX626725S, PZX626726S, PZX626727S, PZX626728S, PZX626729S, PZX626730S, PZX626731S, PZX626733S, PZX626734S, PZX626739S, PZX626744S, PZX626746S, PZX626748S, PZX626759S, PZX626760S, PZX626762S, PZX626763S, PZX626764S, PZX626766S, PZX626767S, PZX626768S, PZX626769S, PZX626770S, PZX626776S, PZX626777S, PZX626783S, PZX626786S, PZX626788S, PZX626789S, PZX626790S, PZX626799S, PZX626802S, PZX626803S, PZX626826S, PZX626837S, PZX626842S, PZX626859S, PZX626895S, PZX626907S, PZX626913S, PZX626915S, PZX626916S, PZX626918S, PZX626928S, PZX626933S, PZX626934S, PZX626949S, PZX626950S, PZX626953S, PZX626954S, PZX626958S, PZX626960S, PZX626964S, PZX626966S, PZX626967S, PZX626970S, PZX626982S, PZX626984S, PZX626986S, PZX626988S, PZX626990S, PZX626993S, PZX626994S, PZX626996S, PZX626997S, PZX626998S, PZX627010S, PZX627012S, PZX627013S, PZX627016S, PZX627021S, PZX627022S, PZX627024S.
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Management; 8200 Coral Sea St NE; Saint Paul MN 55112-4391
• For Additional Information Contact: Medtronic Customer Service; 800-848-9300
• Manufacturer Reason for Recall: Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
• FDA Determined Cause: Nonconforming Material/Component
• Action: Medtronic sent an Urgent Medical Device Recall letter dated June 7, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately return non-implanted devices to Medtronic and to register the implanted ones immediately by calling the Medtronic Patient Registration Department at 1-800-848-9300. Customers with questions were instructed to contact their local Medtronic representative or Medtronic Customer Service at 1-800-848-9300. For questions regarding this recall call 763-526-6000. UPDATE: An Urgent Medical Device Correction letter, dated June 2013, was sent to affected implanting and following physicians beginning June 28, 2013. In the US these letters were hand delivered by a Medtronic representative. Outside the US, the notice will be mailed or hand delivered as determined by the geographic center. The letter informed physicians that they have implanted or are following a patient implanted with a device potentially affected by the connector bracket weld issue. The letter described how a loss of hermeticity may affect the device functionality and what symptoms a patient may experience. The letter also offers patient management recommendations.
• Quantity in Commerce: 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
• Distribution: Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom, Uruguay , and Yemen. UPDATED Physicians location in USA: AL, AR, FL, GA, IL, IN, KS. LA, ME, MI, MN, MO, NY, OH, PA, SC, TN, TX and VA. OUS: Luxembourg
• 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 = NKE and Original Applicant = MEDTRONIC Inc.