Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
FDA Recall Z-0103-2023 · Posted 2022-10-20
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Recalling FirmBALT USA, LLC
Recall StatusOpen, Classified
Product CodeHCG
Date Initiated2022-09-07
Product Quantity41 impacted devices
Reason for Recall
Product pouch label does not match up with carton label
Firm 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
Root Cause
Error in labeling
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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