Optima Coil System embolization coils recalled for defective radiopaque marker
BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was 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 involving a device used for critical vascular procedures where visualization is essential to safe placement. The defect (non-visible radiopaque marker) creates a risk of harm during interventional procedures, although no reported illnesses or injuries are stated in the source text, making it a High rather than Severe rating.
Plain-English summary
BALT USA, LLC is recalling the Optima Coil System, an implantable embolization coil used during vascular interventional procedures. The recalled devices include multiple REF codes and configurations of the Optima Coil System and related OptiBLOCK Coil and Optimax Coil products. A total of 2,889 devices have been distributed worldwide, including across numerous U.S. states and to countries including Canada, Australia, Japan, and others.
The recall was initiated because the radiopaque marker on the Optima Coil System was not visible during angiography and was determined to have not been manufactured to specification. The radiopaque marker is a positioning feature intended to aid visualization during medical procedures.
The Optima Coil System is used with the XCEL Detachment Controller and is used in vascular interventional procedures. Patients and healthcare providers who have received or used these devices should contact BALT USA, LLC or their healthcare provider for instructions regarding the recalled devices.
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
- device-defect
- visibility-impairment
Distribution
Distributed nationwide across the United States.
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