CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report

Optima Coil System recalled by Balt Usa

Balt USA is recalling Optima Coil System, distributed nationwide in the US. The recall was initiated on 7 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

Quantity recalled41 impacted 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-0103-2023
FDA event ID: 90870
Recalling firm: Balt USA, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Sep 2022
FDA classified: 20 Oct 2022
Reported: 26 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

7 Sep 2022	Recall initiated by company
20 Oct 2022	Classified by FDA	+43 days
26 Oct 2022	Published in enforcement report	+6 days

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

Reason for recall

Product pouch label does not match up with carton label

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

Nationwide Florida Georgia North Carolina Pennsylvania

Questions about this recall

Why was it recalled?

Product pouch label does not match up with carton label

Which lots are affected?

Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

Where was it sold?

Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

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
14 Sep 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt USA	Other	AZ, FL

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide