GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Category
- Medical Device
- Distribution
- Distributed nationwide