CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Optima Coil System recalled by Balt Usa

Balt USA is recalling Optima Coil System, distributed in Arizona, Florida. The recall was initiated on 26 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

Quantity recalled4 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1680-2022
FDA event ID: 90724
Recalling firm: Balt USA, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jul 2022
FDA classified: 6 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Jul 2022	Recall initiated by company
6 Sep 2022	Classified by FDA	+42 days
14 Sep 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

Where it was distributed

U.S.: AZ and FL O.U.S.: None

Arizona Florida

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

Where was it sold?

U.S.: AZ and FL O.U.S.: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Balt USA

All 7

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS I	MEGA Ballast Distal Access Platform Mega Ballast recalled by Balt Usa	Balt USA	Device Malfunction	12 states
25 Jun 2025Device	CLASS II	Optima Coil System REFs recalled by Balt Usa	Balt USA	Foreign Material	Nationwide
25 Jun 2025Device	CLASS II	Prestige Coil System REFs recalled by Balt Usa	Balt USA	Foreign Material	Nationwide
14 Feb 2024Device	CLASS II	PRES0413CPKPL Prestige Coil Prestige Plus Complex Pack recalled	Balt USA	Device Malfunction	28 states
26 Oct 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt USA	Device Malfunction	Nationwide

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