Events

Recall of Device Recall Medtronic, Consulta CRTP, Syncra CRTP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Disease Management.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65433
  • Event Risk Class
    Class 2
  • Event Number
    Z-1607-2013
  • Event Initiated Date
    2013-06-07
  • Event Date Posted
    2013-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118886
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
  • Reason
    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.
  • 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.

Device

Device Recall Medtronic, Consulta CRTP, Syncra CRTP
  • Model / Serial
    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, 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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, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    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
  • Product Description
    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

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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