Events

Recall of Device Recall HeartMate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thoratec Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0688-03
  • Event Initiated Date
    2003-02-07
  • Event Date Posted
    2003-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26180
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventricular (Assist) Bypass - Product Code DSQ
  • Reason
    Driveline tubing connections on the svl if under stress condition may snap off, vad support is compromised, a serious injury or death can occur.
  • Action
    The firm issued a Safety Bulletin and Safety Instructions to all consignees via certified mail with return receipts on 2/7/03.

Device

Device Recall HeartMate
  • Model / Serial
    All Codes
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Product was released for distribution to 117 direct accounts nationwide and to 31 foreign accounts including 2 Canadian accounts. [Canadian Consignee #1]: Transplant Surgeon, Dr. Renzo Cecere, MD FRCS(C), Hospital Royal Victoria, Chirurgle Cardio-Thoracique, 687 Ave Des Pins Ouest, Montreal, Quebec, H3A 1A1, Canada [Canadian Consignee # 2]: Transplant Surgeon Dr. Christopher M. Feindel MD FRCS(C), Toronto General Hospital, Division of Cardiothoracic Surgery, Toronto, Ontario, M5G 2CA, Canada.
  • Product Description
    HeartMate Stroke Volume Limiter (SVL) || Catalog # 1295
  • Manufacturer
    Thoratec Corp

Manufacturer

Thoratec Corp
  • Manufacturer Address
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA