Manufacturers

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
  • 2 Events

2 dispositifs dans la base de données

Device Recall Hall EasyFit Prosthetic Heart Valve M
  • Modèle / numéro de série
    USA 23M546512J 23M547083J 23M547084J 23M547626J 23M547629J 23M547631J 23M547896J 23M547905J 25M553329J 25M553855J 25M554621J 27M555072J 27M555079J 27M555083J 27M555646J 27M555654J 27M555789J 27M555842J 29M554274J 29M560938J 29M561157J 29M561320J 29M561328J 29M561456J 31M552397J 31M553444J 31M553650J 31M553713J 31M553762J, and 31M555548J  EUROPE 23M546513J 23M547076J 23M547088J 23M547195J 25M553559J 25M553640J 25M553854J 25M553931J 25M553946J 25M554246J 25M554629J 25M554858J 25M554910J 25M555060J 25M553850J 27M553375J 27M553383J 27M553562J 27M553570J 27M553572J 27M554161J 27M554172J 27M554173J 27M554176J 27M554181J 27M554182J 27M554185J 27M554187J 27M554189J 27M554260J 27M554262J 27M554263J 27M554264J 27M554265J 27M554267J 27M554269J 27M554271J 27M554351J 27M554354J 27M554358J 27M554450J 27M554454J 27M554458J 27M554511J 27M554518J 27M554642J 27M554643J 27M554645J 27M554646J 27M554810J 27M554863J 27M554870J 27M554923J 27M554992J 27M554993J 27M555069J 27M555315J 27M555330J 27M555333J 27M555341J 27M555342J 27M555347J 27M555350J 27M555353J 27M555439J 27M555440J 27M555441J 27M555442J 27M555443J 27M555444J 27M555538J 27M555540J 27M555541J 27M555543J 27M555545J 27M555546J 27M555641J 27M555642J 27M555644J 27M555647J 27M555652J 27M555691J 27M555743J 27M555744J 27M555745J 27M555746J 27M555754J 27M555755J 27M555763J 27M555787J 27M555791J 27M555852J 27M555858J 27M559405J 27M559440J 27M559448J 29M550088J 29M550209J 29M551061J 29M552565J 29M552612J 29M552648J 29M552649J 29M552717J 29M552722J 29M552922J 29M552927J 29M552937J 29M553239J 29M553240J 29M553289J 29M553295J 29M553353J 29M553355J 29M553442J 29M553763J 29M553857J 29M553858J 29M554079J 29M554080J 29M554369J 29M554400J 29M554578J 29M554679J 29M554680J 29M554683J 29M554684J 29M554734J 29M554736J 29M554737J 29M554744J 29M554783J 29M554871J 29M554872J 29M554874J 29M554875J 29M554877J 29M554879J 29M554929J 29M554930J 29M554931J 29M554932J 29M554933J 29M554935J 29M554936J 29M554937J 29M554939J 29M554940J 29M554941J 29M555095J 29M555099J 29M555101J 29M555107J 29M555110J 29M555153J 29M555154J 29M555158J 29M555556J 29M555560J 29M555561J 29M555656J 29M555657J 29M555665J 29M555984J 29M553354J 31M550204J 31M550207J 31M551255J 31M551256J 31M552714J 31M553351J 31M553443J 31M553446J 31M553576J 31M553657J 31M553711J 31M554466J 31M554471J 31M554577J 31M554876J 31M554880J 31M554934J 31M555371J 31M555372J 31M555549J 31M555980J, and 31M556181J  CANADA 27M555436J 31M553577J, and 31M555160J   OTHER 25M553700J 25M553796J 25M553798J 25M553799J 25M553841J 25M553933J 25M553943J 25M553948J 25M554348J 25M554565J 25M554619J 25M554626J 25M554633J 25M554721J 25M554729J 25M554731J 25M554733J 25M554775J 25M554803J 25M554804J 25M554805J 25M554806J 25M554856J 27M553374J 27M554676J 27M554922J 27M554926J 27M554989J 27M555001J 27M555084J 27M555313J 27M555314J 27M555316J 27M555317J 27M555331J 27M555332J 27M555337J 27M555338J 27M555339J 27M555340J 27M555343J 27M555345J 27M555348J 27M555349J 27M555430J 27M555433J 27M555437J 27M555542J 27M555643J 27M555645J 27M555649J 27M555687J 27M555689J 27M555690J 27M555741J 27M555748J 27M555749J 27M555751J 27M555752J 27M555759J 27M555786J 27M555790J 27M555843J 27M555846J 27M555851J 27M555854J 27M555945J 27M559304J 29M553712J 29M554078J 29M554085J 29M554086J 29M554087J 29M554784J 29M554928J 29M555098J 29M555108J 29M555159J 31M553761J 31M554280J 31M554465J 31M554468J 31M554685J 31M554735J 31M555370J 31M555373J 31M555547J 21A555222J 23A555240J 23A555676J 25A554043J 27M555544J 29A554153J 31M549988J, and 31M550134J
  • 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 - Mitral M7700. 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.
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.

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Medtronic Heart Valve Division
  • 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
    SATP