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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that deaths were reported, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Thoratec Corporation is recalling HeartMate II Pocket Controllers that were removed from packaging. The HeartMate II is a mechanical device used to circulate blood throughout the body when the heart is too weak to pump blood adequately on its own.
The recall was initiated due to the discovery of serious injuries and deaths associated with the process of changing from a primary System controller to a back-up System controller in patients using the Pocket System controller model.
A total of 7,436 units are affected. These units have catalog number 105109, which is found on the side of the unit, and include all serial numbers. The devices were distributed worldwide, including nationwide in the United States and in various countries across Europe, the Middle East, and Asia.
The recalled product
- 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.
- Manufacturer
- Thoratec Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 7,436
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number 105109 (found on side of unit) all serial numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by Thoratec Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Thoratec Corporation
See all →- ModerateSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
- ModerateSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
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- ModerateSt. Jude Medical HeartMate II LVAS Software and Hardware Update Recall
FDA (Devices) · 2017-05-31
- CriticalThoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
FDA (Devices) · 2014-04-02
- CriticalThoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries
FDA (Devices) · 2014-04-02
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