medical Class II Updated 2019-08-28

Thoratec Corp. recalls Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief,

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747
View official government recall

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