Boston Scientific recalls Lotus Edge Valve System (25mm) due to risk of deployment failure if visual inspection is skipped. Affected units have specific GTIN and expiration dates.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Boston Scientific is recalling its Lotus Edge Valve System (25mm) because improper visual checks before locking the valve during deployment can cause the delivery system to become stuck. This could prevent the valve from being released properly, potentially causing complications.
If the visual inspection step is skipped before locking the valve during deployment, the delivery system may not release properly. This could cause the valve to become stuck, preventing the intended medical procedure from completing successfully.
Patients who have received the Lotus Edge Valve System (25mm) from Boston Scientific are affected. Those with the specific GTIN 08714729960911 and expiration dates between Nov 2, 2020 and Oct 29, 2021 are most at risk.
Check for the GTIN 08714729960911 on the packaging. The product was made in Ireland and has expiration dates from November 2, 2020 through October 29, 2021.
Look for the GTIN 08714729960911 and expiration dates between November 2, 2020 and October 29, 2021 on the packaging.
The product is safe if the visual inspection step is completed correctly before locking the valve during deployment.
The official recall notice does not specify a remedy or action for affected products.
Check for the GTIN 08714729960911 and expiration dates between November 2, 2020 and October 29, 2021 on the packaging.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0729-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0729-2021 from Boston Scientific. 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.
