Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thoratec HeartMate 3 Coring Tool Recalled by Thoratec Corp. Due to Small black plastic particle was observed in the...
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 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
Quantity: 650
Why Was This Recalled?
Small black plastic particle was observed in the left ventricle during implant procedure.
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