FDA Medical Device Recalls (openFDA)
BALT USA, LLC: Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
- Recall number
- Z-0103-2023
- Recalling firm
- BALT USA, LLC
- Product
- Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
- Status
- Open, Classified
- Initiated
- 2022-09-07
- Posted
- 2022-10-20
- Terminated
- not on file
- Reason
- Product pouch label does not match up with carton label
- 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 - QA@baltgroup.com telephone number - 949-788-1443 or Fax 949-788-1444
- Quantity
- 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.
- Lot, serial or model codes
- Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
- 510(k) numbers
- ["K172390","K200030"]
- PMA numbers
- not on file
- Product code
- HCG
- Firm FEI
- 3014162263
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28