---
title: "Optima Coil System Model OPTI0520CSF10. For endovascular embolization. — FDA record Z-1680-2022 | Is It on Recall"
description: "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."
url: https://isitonrecall.com/recall/fda-device-z-1680-2022-optima-coil-system-model-opti0520csf10-for-endovascular-embolization/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1680-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [Florida](https://isitonrecall.com/state/florida/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1680-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [BALT USA, LLC records](https://isitonrecall.com/brand/balt-usa-llc/)