Thoratec Corp. recalls Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/1
See all recalls from Thoratec Corp. →Recalled Product
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
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: 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
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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