Boston Scientific recalls Lotus Edge Valve System (25mm) due to risk of deployment failure if visual inspection is skipped during valve locking. 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 can cause the delivery system to become stuck during deployment. This could prevent the valve from being released properly, potentially causing complications.
If the visual inspection step is skipped when locking the valve during deployment, the delivery system may not release properly. This could cause the valve to become stuck, preventing the intended valve release and potentially requiring additional procedures.
Patients who have received the Lotus Edge Valve System (25mm) for aortic valve replacement are affected. Medical professionals using the device during procedures are at higher risk.
Check for the product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile'. The GTIN is 08714729940821. Units were made in Ireland with expiration dates from November 2, 2020, through October 29, 2021.
Review the device's visual inspection steps before locking the valve during deployment to ensure proper release.
This recall applies to patients who received the Lotus Edge Valve System (25mm) for aortic valve replacement. Check your product details to confirm.
Look for the GTIN 08714729940821 on the packaging. The product was made in Ireland with expiration dates from November 2, 2020, through October 29, 2021.
The recall does not specify a return or replacement process. Check with Boston Scientific for guidance on proper use to avoid deployment issues.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0735-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0735-2021 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.
