Reported Feb 8, 2023 · Ongoing
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W L Gore & Associates, Inc. · 3750 W Kiltie Ln · Flagstaff, AZ · 86005-8712
Is this the product you have?
- GORE CARDIOFORM Septal Occluder
- REFGSX0030A
- Lot codes and dates
- UDI-DI/Serial Numbers
00733132631032/2555638825556389255563902555639125556392255563932555639425556398255563992555640025556401255564022555640325556406
- UDI-DI/Serial Numbers
- Amount recalled
- 14
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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