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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly reports deaths and serious injuries, which mandates a Critical severity score of 5 according to the rubric.
Plain-English summary
Thoratec Corporation is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits (Catalog number 107801, all serial numbers). 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.
The affected units were distributed worldwide, including nationwide in the United States and in 20 other countries. Patients using the HeartMate II system should contact their healthcare provider or Thoratec Corporation for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Thoratec Corporation
- Hazard
- Affected units
- 36
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 107801 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 →- SevereSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
- SevereSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
- SevereSt. Jude Medical HeartMate II LVAS Software and Hardware Update Recall
FDA (Devices) · 2017-05-31
- CriticalThoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
FDA (Devices) · 2014-04-02
- CriticalThoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
FDA (Devices) · 2014-04-02
Same hazard · serious injury
See all →- SevereLaziza Dressers Recalled Due to Tip-Over and Entrapment Hazards
CPSC · 2026-08-06
- Critical
- Severe
- Critical
- Critical
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