Recall Z-1048-2023— W L Gore & Associates, Inc.
Class II · Ongoing
Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2022-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: GORE CARDIOFORM Septal Occluder, REF: GSX0030A. Reason: Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture..
- Recalling firm
- W L Gore & Associates, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-14
- Firm location
- Flagstaff, AZ, United States
Product description
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Reason for recall
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.