Z-0103-2023Class II

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

Name: Z-0103-2023 Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures
Creator: Balt USA, Llc
Published: 2022-09-07
License: https://open.fda.gov/license/

Balt USA, LLC / initiated 2022-09-07 / Open, Classified / root cause: labeling and UDI

FDA source

BALT USA, LLC began a recall of Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures on 2022-09-07. FDA classified it as Class II and gives the reason as "Product pouch label does not match up with carton label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0103-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-07
Posted: 2022-10-20
Recalling firm: Balt USA, LLC
Product: Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product code: HCG Device, Neurovascular Embolization
Reason for recall: Product pouch label does not match up with carton label
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 09/07/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via priority mail to customer informing them that Balt USA was informed that one device had information on the pouch label that differed from the information on the carton label. This hazard presents a high risk to patient safety with the possibility that the user could inadvertently select the wrong size coil for a procedure. Distributor/Subsidiaries are instructed to: -Inform customers about this notice. -Return to Balt USA products from Lot #F2206001068 and Lot #F220601089 Direct Customers are instructed to: -Inform within their hospital Safety Office, Pharmacists, Head of Neuroradiology and staff of Recall. -Return to Balt USA products from Lot #F2206001068 and Lot #F220601089 For questions or assistance - contact Balt USA Quality Department at email - [email protected] telephone number - 949-788-1443 or Fax 949-788-1444
Quantity in commerce: 41 impacted devices
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Product codes and lots: Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0103-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20

Product code HCG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)