Events

Rappel de Device Recall Medtronic Mosaic Porcine Bioprostheses with Cinch

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    51220
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1225-2009
  • Date de mise en oeuvre de l'événement
    2009-01-26
  • Date de publication de l'événement
    2009-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79251
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Replacement Heart-Valve - Product Code DYE
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot Serial Number  21A06D2415, 27A05F7021, 23A06W1410, 25A04V1591, and  29A07F0075.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.
  • Description du dispositif
    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
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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