Events

Rappel de Device Recall Thoratec TLCII Portable VAD driver

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
    38325
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1108-2007
  • Date de mise en oeuvre de l'événement
    2007-06-08
  • Date de publication de l'événement
    2007-07-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53406
  • 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 Device System (VAD) - Product Code DSQ
  • Cause
    Component failure; device failure without warning; due to premature wear-out of the compressor motor, vad support for the patient's circulatory system may fail without warning.
  • Action
    Urgent Medical Device Recall letters, dated June 08, 2007, were issued to consignees, with instructions to take the following actions: 1) check the current number of service hours on all units. 2) do not use TLC-II drivers exceeding 1500 hours until they are serviced by thoratec. 3) note the indicated hours on the product inventory form and return the form to Thoratec. 4) ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures. The firm is also arranging for the return and servicing of all affected drivers, with highest priority to those drivers already exceeding 1500 hours of life. A July 19, 2007, Press Release was issued by the firm.

Device

Device Recall Thoratec TLCII Portable VAD driver
  • Modèle / numéro de série
    Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.
  • Description du dispositif
    Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
  • Manufacturer
    Thoratec Corp

Manufacturer

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