Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GORE CARDIOFORM Septal Occluder Recalled by W L Gore & Associates, Inc. Due to Septal Occluders released with incomplete quality test documentation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact W L Gore & Associates, Inc. directly.
Affected Products
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Quantity: 14
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About W L Gore & Associates, Inc.
W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report