HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect
The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.
- Product
- Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
- Category
- Medical Device
- Distribution
- Distributed nationwide