Events

Retiro De Equipo (Recall) de Device Recall Hall EasyFit Prosthetic Heart Valve M

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Heart Valve Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47795
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1775-2008
  • Fecha de inicio del evento
    2008-03-25
  • Fecha de publicación del evento
    2008-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70253
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Medtronic has identified an issue with 685 hall easy-fit¿ valves models a7700 and m7700 in which the holder of the valve was incorrectly secured to the valve. this could potentially make it difficult to easily disengage the holder from the valve.
  • Acción
    A Medtronic "Urgent Communication" letter dated March 24, 2008 was sent to consignees on 3/25/08. The letter describes the product and problem. The letter requests that they return the impacted devices and to return the reconciliation form "Medtronic Recall Certificate (FCA0807)" confirming whether they have the valves in inventory or if they have been implanted.

Device

Device Recall Hall EasyFit Prosthetic Heart Valve M
  • Modelo / Serial
    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
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Medtronic Heart Valve Division

Manufacturer

Medtronic Heart Valve Division
  • Dirección del fabricante
    Medtronic Heart Valve Division, 8299 Central Ave Ne, Spring Lake Park MN 55432-2023
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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