Events

Rappel de THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

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
    Recall
  • ID de l'événement
    50091
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0496-2009
  • Date de mise en oeuvre de l'événement
    2008-10-24
  • Date de publication de l'événement
    2008-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74710
  • 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
    The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the heartmate ii left ventricular assist system (hm ii lvas) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.
  • Action
    An initial "Urgent: Medical Device Correction" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return response (Acknowledgement Form) was included with the letter for consignees to complete and fax it to Thoratec Regulatory Affairs at 925-847-8628. Direct questions to the Thoratec Regulatory Affairs Department at 925-730-4135 (Monday-Friday, 8 a.m.-5 p.m. PST). Clinicians and patients with questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.

Device

THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
  • Modèle / numéro de série
    All serial numbers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. || Product is manufactured and distributed by Thoratec Corporation, || Pleasant, CA. || The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corp

Manufacturer

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