The Optima Coil System consists of an implantable embolization coil… — Class II medical device recall Z-0660-2022
Ongoing recall by BALT USA, LLC, reported 2022-03-02, distributed nationwide. Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to ina
| Recall number | Z-0660-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BALT USA, LLC, Irvine, CA, United States |
| Recall initiated | 2022-01-04 |
| Classified | 2022-02-22 |
| Reported by FDA | 2022-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, DK, ES, FR, LB, NL, PE, PT, SE, SI |
| Quantity | 51 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00818053026010, 00818053026096 |
| Lot numbers | F210500134, F210500135 |
| Model numbers | OPTI0204CSF10, OPTI0407CSF10 |
Product
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.
Reason for recall
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
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-0660-2022. 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.