BALT USA, LLC is recalling 207 MEGA Ballast Distal Access Platform catheters because a manufacturing defect can cause the inner coating of the device to lift or peel. This recall affects four specific model numbers and 16 production lots distributed to medical facilities in 12 U.S. states. The issue was discovered during the manufacturing process and affects the device's distal inner lumen.
The coating material inside the catheter may detach and enter the patient's bloodstream during a medical procedure. This poses a serious risk of blood clots, vessel blockage (embolism), stroke, or other critical life-threatening injuries.
Quantity affected: 207 catheters.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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