W L Gore recalls specific GORE CARDIOFORM ASD Occluder implants due to failed manufacturing tests. Affected units have unique model and serial numbers. Consumers should contact the company for details.
Due to manufacturing records (Release Test Results) indicating "Failed".
W L Gore is recalling certain GORE CARDIOFORM ASD Occluder cardiovascular implants because manufacturing tests showed they failed. This means the devices may not work safely in the body and could cause health risks.
The recall is based on manufacturing records showing the devices failed a critical test. This means the implants might not function properly and could lead to complications if used in the body.
People who own or use the recalled GORE CARDIOFORM ASD Occluder implants are affected. Those with the specific model numbers and serial numbers listed are most at risk.
Check the model number (ASD37A, ASD44A, or ASD44E) and serial numbers listed in the recall notice. The devices are cardiovascular implants used for heart conditions.
Identify your model number and serial number to confirm if it's in the recall list.
The recall is due to manufacturing records showing the devices failed a critical test.
Check if your model number and serial number match those listed in the recall notice.
Contact W L Gore directly for instructions on what to do next.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0136-2023 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0136-2023 from W L Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
