Recall archive / FDA device enforcement
Optima Coil System Model OPTI0520CSF10. For endovascular embolization. — FDA record Z-1680-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- BALT USA, LLC
- Quantity
- 4 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1680-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AZ and FL O.U.S.: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Jul 26, 2022
- Center classification date
- Sep 6, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.