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FDAMarch 30, 2019device

Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

thoratec

UPCs

00813024013266

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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