BALT USA, LLC Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Brand
BALT USA, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
BALT USA, LLC is recalling Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular due to Product pouch label does not match up with carton label. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product pouch label does not match up with carton label
Recommended Action
Per FDA guidance
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 - QA@baltgroup.com telephone number - 949-788-1443 or Fax 949-788-1444
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026