Device Recall Thoratec

  • Model / Serial
    Serial Numbers: 104, 106
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.
  • Product Description
    Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, || Model Number(s): Catalogue numbers: || #100118-- Short, 14mm graft; || #100121-- Long, 14mm graft; || #100129-- Long, 18mm graft. || Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588-3270
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 17482
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.
  • Product Description
    Thoratec Sterile LVAD Pneumatic Lead 5'' ; || Model/Product Number: 20010-0000-108
  • Manufacturer
  • Model / Serial
    All Codes (Valve Disk Lot 20052904)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution-USA including states of AL, CA, CT, FL, IL, IN, KY, LA, MA, ME, MI, MN, NC, NY, OH, PA, TN, TX, VA, WA, and WI., with 19 Foreign consignees Australia, Belgium, Canada*, Czech Republic, France, Germany, Ireland, Netherlands, Portugal, Switzerland, United Kingdom. (*Hospital Royal Victoria, Queen Elizabeth II/Capital Health, St. Paul's Hospital, Vancouver, Canada.)--
  • Product Description
    Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 || Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
  • Manufacturer
  • Model / Serial
    Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
  • Manufacturer
  • Model / Serial
    Catalog Number 14086-2550-000, bearing serial numbers 10745 or less
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
  • Product Description
    Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
  • Manufacturer