BALT USA, LLC is recalling approximately 34,587 Optima, Optimax, and Prestige Coil Systems used to treat brain aneurysms and other blood vessel abnormalities. Discoloration was found on the delivery pusher component, which was determined to be corrosion caused by leftover solder flux residue. If this material breaks off during a procedure, it could travel through the delivery system into the patient's blood vessels. Consumers and medical professionals should contact their healthcare provider or the manufacturer regarding affected devices.
The corrosion on the delivery pusher can cause small pieces of material to mechanically break off. These fragments may flow through the surgical catheter and into the patient's bloodstream, potentially causing a blockage or foreign emboli in the vasculature.
healthcare provider or manufacturer notification
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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