Devices

Device Recall Medtronic, Consulta CRTP, Syncra CRTP

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • 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
  • Description du dispositif
    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.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management
  • 1 Event

Fabricant

Medtronic Inc. Cardiac Rhythm Disease Management
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA