Drug recall
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into…
FDA recall event 93751 · Class II · BALT USA, LLC
Key facts
| Event ID | 93751 |
|---|---|
| Recall numbers | Z-1041-2024, Z-1042-2024 |
| Recalling firm | BALT USA, LLC |
| Product type | Devices |
| Products | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and…, The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue… |
| Initiation date | Jan 3, 2024 |
| Report date | Feb 14, 2024 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3014162263 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: