Optima Coil System recall
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Why was Optima Coil System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
- Product
- Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
- Recalling firm
- BALT USA, LLC
- Quantity
- 4 devices
- Distribution
- U.S.: AZ and FL O.U.S.: None
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)