FDA Device recall Z-0734-2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 087147299…
- FDA Device
- Class I
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class I recall of Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 087147299… by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0734-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-11-17 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | 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 |
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
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.
Identifiers
| code_info | GTIN 08714729940814, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2021%22
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