Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief Recalled by Thoratec Corp. Due to Outflow Graft leaking at the pump connection during...
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 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
Quantity: 149 outflow graft units
Why Was This Recalled?
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the 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