Boston Scientific recalls Lotus Edge Valve System 27mm for potential 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 transplanted heart valve product because improper visual checks during deployment could prevent the delivery system from being released. This could lead to complications during the procedure if the valve isn't properly deployed.
If the medical team skips the visual inspection step before locking the valve during deployment, the delivery system might not release properly. This could cause the valve to become stuck in the heart, requiring emergency intervention.
Medical professionals using the Lotus Edge Valve System during heart valve procedures are most at risk. Patients receiving this device during surgery may be affected if the deployment fails.
Check for the product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270' with GTIN 08714729960928. The product was made in Ireland and expires between November 2, 2020, and October 29, 2021.
Review the product's deployment process to ensure visual inspection is completed before locking the valve.
The product is safe if the visual inspection step is followed correctly during deployment. Failure to do so could cause deployment issues.
The product expires between November 2, 2020, and October 29, 2021.
Check for the GTIN 08714729960928 and product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270' 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-0730-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0730-2021 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.
