BALT USA, LLC Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Brand
BALT USA, LLC
Lot Codes / Batch Numbers
Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
Products Sold
Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
BALT USA, LLC is recalling Optima Coil System Model OPTI0520CSF10. For endovascular embolization. due to 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 s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
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 noticeDistribution
As reported by FDA
AZ, FL
Page updated: Jan 10, 2026