The Recall Desk

FDA (Devices) recall action 67639

Thoratec Corporation recalled 4 products on 2014-04-02

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2014-04-02
Critical
4
Units
11,592

Why these products were recalled

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • CriticalFDA (Devices)··2014-04-02

    Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths

    Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.

    Product
    Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Distribution
    35 states
  • CriticalFDA (Devices)··2014-04-02

    Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports

    Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.

    Product
    HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.
    Category
    Distribution
    35 states
  • CriticalFDA (Devices)··2014-04-02

    Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries

    Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.

    Product
    HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Distribution
    35 states
  • CriticalFDA (Devices)··2014-04-02

    Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries

    Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.

    Product
    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Distribution
    35 states