Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GORE CARDIOFORM ASD Occluder. cardiovascular implant. Recalled by W L Gore & Associates, Inc. Due to Due to manufacturing records (Release Test Results) indicating...
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 ASD Occluder. cardiovascular implant.
Quantity: 98 units
Why Was This Recalled?
Due to manufacturing records (Release Test Results) indicating "Failed".
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