GORE CARDIOFORM ASD Occluder Cardiovascular Implants Recalled for Manufacturing Test Failure
W L Gore & Associates is recalling 98 GORE CARDIOFORM ASD Occluder cardiovascular implants due to failed manufacturing release test results. Affected units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This product is classified as FDA Class II. Although no illnesses, injuries, or deaths are reported in the source text, a cardiovascular implant with failed manufacturing release test results qualifies as a 'risk-of-harm product where injury has not yet been reported,' meeting the criterion for severity score 3 (High) per the rubric.
Plain-English summary
W L Gore & Associates is recalling GORE CARDIOFORM ASD Occluder cardiovascular implants. The recall affects 98 units distributed worldwide.
The recall was initiated due to manufacturing release test results indicating failure.
Affected units were distributed in the United States, Denmark, and Japan. U.S. distribution includes Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Maine, Minnesota, North Carolina, New York, JPA, Tennessee, Texas, Washington, and Wisconsin.
The recalled product
- Product
- GORE CARDIOFORM ASD Occluder. cardiovascular implant.
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- Affected units
- 98
Distribution
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