Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0506-2026.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0506-2026.
Recall ongoing. Follow firm instructions.
✅ 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 Llc 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-0506-2026.
Thoratec LLC
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.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
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 Llc Recall FAQ
Thoratec Llc is the subject of a medical implants safety report: Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106.... The notice was published on October 9, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 35,376 units are potentially affected.