BALT USA, LLC is recalling 4,643 units of its Optima and Prestige Coil Systems because a critical radiopaque marker used to see the device during surgery might not be visible. These implantable coils are used in hospitals and medical centers for specialized vascular procedures. No incidents or injuries have been reported, but the defect was discovered when markers were found to be manufactured incorrectly.
If the positioning marker is not visible during an angiography procedure, doctors may not be able to accurately place or detach the coil inside the patient. This defect could lead to surgical complications, delays, or the need for device replacement during sensitive medical procedures.
Implantable embolization coils. Optima Coil delivery pusher is 185cm in length.
Implantable embolization coils. Optima Coil delivery pusher is 185cm in length.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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