Optima Coil System embolization devices recalled for defective radiopaque markers
BALT USA is recalling Optima Coil System implants due to radiopaque markers not being visible during angiography. The markers were not manufactured to specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an interventional medical device with a manufacturing defect affecting a critical safety component. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) score.
Plain-English summary
The Optima Coil System and OptiBLOCK Coil variants manufactured by BALT USA, LLC are being recalled due to manufacturing defects affecting the radiopaque markers used to visualize devices during angiography procedures. The radiopaque markers were not visible during angiography and did not meet manufacturing specifications.
The recall affects approximately 2,889 devices distributed worldwide and throughout the United States.
Patients and healthcare providers who have received these devices should contact BALT USA, LLC or the treating facility to determine whether a specific device is affected and to discuss appropriate clinical follow-up.
The recalled product
- Product
- Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 008
- Manufacturer
- BALT USA, LLC
- Hazard
- radiopaque-marker-defect
- visibility-impairment
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03