Device Recall Thoratec

  • Modèle / numéro de série
    Serial Numbers: 104, 106
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588-3270
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Lot Number: 17482
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Thoratec Sterile LVAD Pneumatic Lead 5'' ; || Model/Product Number: 20010-0000-108
  • Manufacturer
  • Modèle / numéro de série
    All Codes (Valve Disk Lot 20052904)
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.)--
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.
  • Classification du dispositif
  • 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
  • Modèle / numéro de série
    Catalog Number 14086-2550-000, bearing serial numbers 10745 or less
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
  • Description du dispositif
    Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
  • Manufacturer