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 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 (23mm) because improper visual checks during valve deployment could cause the delivery system to become stuck. This affects patients who have the specific model with the listed GTIN and expiration dates.
If the visual inspection step is skipped when locking the valve during deployment, the delivery system may not release properly. This could cause the device to become stuck in the patient's body, potentially requiring additional procedures.
Patients who have received the Lotus Edge Valve System (23mm) with the specific GTIN 08714729940814 and expiration dates from November 2020 through October 2021 are most at risk. Healthcare providers using this device for cardiac procedures may also be affected.
Check for the GTIN 08714729940814 on the packaging. The product was made in Ireland and has expiration dates between November 2, 2020, and October 29, 2021.
Verify the GTIN 08714729940814 and expiration dates on the packaging to confirm if your device is affected.
The recall applies to the Lotus Edge Valve System (23mm) with GTIN 08714729940814 and expiration dates from November 2, 2020, through October 29, 2021. Check your packaging for these details.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance on next steps.
Look for the GTIN 08714729940814 on the packaging and check that the expiration date falls 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-0734-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0734-2021 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.
