Devices

Device Recall Hall EasyFit Prosthetic Heart Valve A

  • Modèle / numéro de série
    USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J  EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and  CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J   OTHER 19A553455J 19A553748J 19A553881J 19A553901J 19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA states of TX, WY, CA, MI, WI, MO, IL, NY, TN, AR, LA, KY, WA, WV, and countries of Canada, Hong Kong, Australia, Albania, Belgium, Croatia, Germany, India, Italy, Netherlands, Poland, Romania, Russian Federation, South Africa, and Turkey.
  • Description du dispositif
    Hall Easy-Fit¿ Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.
  • Manufacturer
    Medtronic Heart Valve Division
  • 1 Event

Fabricant

Medtronic Heart Valve Division
  • Adresse du fabricant
    Medtronic Heart Valve Division, 8299 Central Ave Ne, Spring Lake Park MN 55432-2023
  • 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