PASCAL Transcatheter Valve Repair System Affected by Manufacturing Defect
Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.
- Product
- PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
- Category
- Medical Device
- Distribution
- 0 states