BALT USA Optima Coil System Model OPTI052: Endovascular Embolization Recall
BALT USA recalls Optima Coil System Model OPTI0520CSF10 for endovascular embolization due to release before test report approval from alternate supplier.
Recall notice
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.
Contact the company
What happened, in plain English
BALT USA is recalling its Optima Coil System Model OPTI0520CSF10 for endovascular embolization. The recall is because these products were released to customers before receiving approval for a test report from an alternate supplier. Read more at govinfonow.com/recall/60310-balt-usa-optima-coil-system-model-opti052-endovascular-embolization-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60310-balt-usa-optima-coil-system-model-opti052-endovascular-embolization-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1680-2022
Cite this page
“BALT USA Optima Coil System Model OPTI052: Endovascular Embolization Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60310-balt-usa-optima-coil-system-model-opti052-endovascular-embolization-recall. Based on FDA recall #Z-1680-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2022%22&limit=1).
Why it’s dangerous
The products were released to customers before the test report authorizing the use of an alternate supplier's material was approved. This could mean the material used in the device hasn't been fully tested for safety and effectiveness.
Who’s affected
Medical professionals using the Optima Coil System for endovascular procedures are likely affected. Patients undergoing these procedures may be at risk if they have the recalled model.
How to tell if you have this one
Check for the model number OPTI0520CSF10 on the device or packaging. The UDI-DI code 00818053026164 and lot number F220600470 are also associated with this recall.
- Brand
BALT USA- Category
Medical device
What to do — step by step
Check Device Details
Look for the model number OPTI0520CSF10 on the device or packaging.
Where it went and when
Where it was distributed
Distributed in Arizona and Florida.
FDA distribution: “U.S.: AZ and FL O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this product?
The recall record does not describe a specific hazard mechanism that could cause injury, so the risk level is unknown.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1680-2022 (July 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1680-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.