Class 2 Device Recall Optima Coil System

• Date Initiated by Firm: July 26, 2022
• Create Date: September 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1680-2022
• Recall Event ID: 90724
• 510(K)Number: K172390 K200030
• Product Classification: Device, neurovascular embolization - Product Code HCG
• Product: Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
• Code Information: Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
• Recalling Firm/ Manufacturer: BALT USA, LLC; 29 Parker Ste 100; Irvine CA 92618-1667
• For Additional Information Contact: Mr. Moises Colin; 949-788-1443 Ext. 765
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On or about 07/15/2022, Balt USA LLC communicated an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" Letter informing customers that Balt became aware that finished goods were released and distributed to customers prior to the approval and release of a test report authorizing the use of existing material from an alternate supplier. On 08/08/2022 and updated/revised "URGENT MEDICAL DEVICE RECALL" letter was sent via certified mail to customers re-emphasizing the recall and providing updated instructions Customer are instructed to: -Inform within their hospital safety officers, pharmacists, head of neuroradiology and the neuroradiology department staff, as well as any other person. -Return to Balt USA any unused product from lot #F220600470: +Collect and put in quarantine the Optima products concerned by this recall and then return them to Balt USA through the usual "RMA" (Return Material Authorization) procedure by contacting Balt USA's Customer Service Department +Keepj informed Balt USA about the status of every unit of Optima products concerned by this recall; +Fulfill the "Notice of receipt" then return to Balt USA via the indicated contact. -If product from lot #F220600470 has been used, no further action is required. For question contact - Quality Department at QA@baltgoup.com or telephone number 949-788-1443 or Fax Number: 949-788-1444
• Quantity in Commerce: 4 devices
• Distribution: U.S.: AZ and FL O.U.S.: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HCG; 510(K)s with Product Code = HCG