Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
Check against the official notice below — it lists the full affected range.
Thoratec Corp. is recalling 149 units of its Heartmate 3 Sealed Outflow Graft, a component of a left ventricular assist device (LVAD) used to help the heart pump blood. The graft can leak at its connection to the pump during implantation if the C-Ring (a sealing component) is not properly seated, which would make the device nonfunctional.
The affected outflow grafts were distributed worldwide to medical facilities in numerous countries including the United States, Canada, Australia, and many European and other nations. The recalled units include all batch and lot numbers 6613000 and below or 50000000 and higher, with a shelf life of 60 months from manufacture date. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 149 outflow graft units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.