Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Thoratec HeartMate 3 Recalled by Thoratec Corp. Due to Potential for a leak path at the seal...
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 Corp. directly.
Affected Products
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Quantity: 882 units
Why Was This Recalled?
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Thoratec Corp.
Thoratec Corp. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report