Devices

Device Recall Medtronic, Consulta CRTP, Syncra CRTP

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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
  • 제품 설명
    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

제조사

Medtronic Inc. Cardiac Rhythm Disease Management
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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