Heartstring III 4.3 mm seal systems recalled over loading and deployment failures
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
- Product
- Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
- Category
- Medical Device
- Distribution
- Distributed nationwide