Rappel de HeartMate 12 volt sealed lead acid Battery Clips

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 Thoratec Corp.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Ventricular (Assist) Bypass - Product Code DSQ
  • Cause
    Patient reports alerted thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. the problem affects heartmate 12v sla battery clips including those used for the heartmate ii lvas and heartmate xve systems. if not detected and handled.
  • Action
    Firm has issued a notification letter to consignees, dated October 14, 2009 asking them to return proof of receipt, and to remove all affected unused devices from stock, and asking ongoing patients to return to hospitals for inspection, replacement if needed, and retraining on the process of switching power sources and safely switching to a back-up system controller. Contact Thoratec Customer Services at 1-800-456-1477 for any questions or concerns about this issue.


  • Modèle / numéro de série
    Lot numbers are visible on the clips: 458560206, 581080207, 581080507, 34331720107, 34404690108, 34532990109, 343317201407, 34331720207,34331720507, 34404690208, 34404690308, 34404690408, 34432810108, 34450070108, 34477720108, 34570570109, 34577730109, 34331720307.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide - USA- AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the District Columbia. Internationally to Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Lithuania, Luxembourg, Monaco, Netherlands, Singapore, South Africa, Sweden, Switzerland, Taiwan and the UK.
  • Description du dispositif
    HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. || The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.
  • Manufacturer


  • Adresse du fabricant
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source