Boston Scientific recalls Lotus Edge Valve System (23mm) due to risk of deployment failure if visual inspection is skipped during valve locking. Affected units have specific lot numbers 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 (23mm) because improper visual inspection 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 during medical procedures.
The valve system requires a visual check before locking to ensure the delivery system can be released after deployment. If this check is skipped, the delivery system may become stuck, preventing the valve from being properly released and potentially causing complications during the procedure.
Patients undergoing aortic valve replacement procedures who use the recalled Lotus Edge Valve System. Medical professionals performing the procedure are most at risk if they use the affected units.
Check for the product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile' with the specific GTIN 08714729960904. Affected units have expiration dates from November 2, 2020, through October 29, 2021.
Identify the product name and GTIN 08714729960904 to confirm if your unit is affected.
Reach out to your healthcare provider to discuss whether the valve system needs to be replaced or adjusted.
The recall applies to specific units with the GTIN 08714729960904 and expiration dates from November 2, 2020, through October 29, 2021. Check your product details to confirm.
Contact your healthcare provider to discuss replacement or adjustment options, as the recall requires medical evaluation.
Look for the product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile' with the GTIN 08714729960904 and expiration dates between November 2, 2020, and October 29, 2021.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0728-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0728-2021 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.
