Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Check against the official notice below — it lists the full affected range.
Thoratec Corp. is recalling 7,200 HeartMate 3 Left Ventricular Assist System implant kits distributed worldwide because the Outflow Graft may leak at the pump connection during implantation if the C-Ring is not properly seated. This leakage renders the device nonfunctional during the implant procedure. The affected product has reference number 106524/106524US and includes all batch/lot numbers 6613000 or 50000000 and higher, with a 36-month shelf life from manufacture date.
The recall affects devices distributed in the United States and numerous countries including Canada, Australia, United Kingdom, Germany, France, Italy, Switzerland, Austria, and others. The source document does not specify a remedy or recommended action 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: 7200 left ventricular assist systems Lot/code info: 106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher. UDI/GMDN 00813024013297 / 47533
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.