Events

Retiro De Equipo (Recall) de Device Recall Medtronic Mosaic Porcine Bioprostheses with Cinch

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 Inc.

¿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
    51220
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1225-2009
  • Fecha de inicio del evento
    2009-01-26
  • Fecha de publicación del evento
    2009-05-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79251
  • 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
    Replacement Heart-Valve - Product Code DYE
  • Causa
    Medtronic identified several heart valves (mosaic porcine bioprosthesis with cinch & hancock ii bioprosthesis with cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 f (25 c) maximum storage temperature published on the labeling. the product is being retrieved as they do not meet the handling requirements.
  • Acción
    A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.

Device

Device Recall Medtronic Mosaic Porcine Bioprostheses with Cinch
  • Modelo / Serial
    Lot Serial Number  21A06D2415, 27A05F7021, 23A06W1410, 25A04V1591, and  29A07F0075.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.
  • Descripción del producto
    Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca. || Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Dirección del fabricante
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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