Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (sterility issue). 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-1692-2024.
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1692-2024.
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 Corp. 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-1692-2024.
Thoratec Corp.
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 Corp. Recall FAQ
Thoratec Corp. is the subject of a medical implants safety report: Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. The notice was published on March 1, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 882 units are potentially affected.