Thoratec Corp. recalls Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventric…

Recall date

March 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2349-2019

FDA classification

Class II

Brand / firm

Thoratec Corp.

Sold / distributed

Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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