Boston Scientific recalls Lotus Edge Valve System (27mm) 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 (27mm) because improper visual checks before locking the valve during deployment could cause the delivery system to become stuck. This affects patients who have had the device implanted using this specific model.
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 in the heart, requiring additional procedures.
Patients who received the Lotus Edge Valve System (27mm) from Boston Scientific in Ireland between 2020 and 2021 are most at risk. The recall applies to specific sterile delivery systems with the GTIN 08714729940838.
Check for the GTIN 08714729940838 on the packaging. The product was made in Ireland and sold between November 2020 and October 2021. The device is a sterile 27mm trans catheter aortic valve prosthesis.
Verify the GTIN 08714729940838 and expiration dates (2-Nov-2020 to 29-Oct-2021) on the packaging.
The recall is due to a risk that skipping the visual inspection step before locking the valve during deployment could cause the delivery system to become stuck.
Look for the GTIN 08714729940838 on the packaging. The product was made in Ireland and sold between November 2020 and October 2021.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0736-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0736-2021 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.
