FDA Device recall Z-1680-2022
Optima Coil System Model OPTI0520CSF10
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Optima Coil System Model OPTI0520CSF10 by Balt Usa, citing products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1680-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-26 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Balt Usa |
| Distribution | AZ, FL |
Product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Reason
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Identifiers
| code_info | Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2022%22
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