HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the ...
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (injury). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1228-2014.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1228-2014.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Thoratec Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1228-2014.
Thoratec Corporation
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Thoratec Corporation Recall FAQ
Thoratec Corporation is the subject of a medical implants safety report: HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the .... The notice was published on March 4, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 4,120 units are potentially affected.