Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
HeartMate II Implant Kit with Pocket Controller Recalled by Thoratec Corporation Due to Discovery of serious injuries and deaths associated with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Thoratec Corporation directly.
Affected Products
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.
Quantity: 1737 catalog number 106015; 609 catalog number 106016
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Thoratec Corporation
Thoratec Corporation has 7 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report