Lotus Edge Valve System — Class I medical device recall Z-0734-2021
Terminated recall by Boston Scientific Corporation, reported 2021-01-20, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. Failure to execute the visual inspection correctly prior to locking the valve during the deployment process ca
| Recall number | Z-0734-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2021-01-09 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2022-01-24 |
| Distributed | AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IT, JP, KR, LU, NL, NO, PL, PT, SE |
| Quantity | 207 devices |
| UPC / GTIN / UDI-DI | 08714729940814 |
| Model numbers | H749LVS230 |
| Expiration dates | 2020-11-02 |
Product
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0734-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.