SUMMA THERAPEUTICS, LLC is recalling 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter. The recall was initiated because the balloons in these devices may not meet specific burst pressure requirements during medical procedures. Consumers should be aware that this issue affects specific lot numbers of model FS252251502 distributed in Florida and New Jersey.
If the balloon fails to meet burst specifications, it may rupture or leak during a procedure, potentially causing vessel injury, internal bleeding, or requiring additional medical intervention to retrieve device fragments.
Recall #: Z-1704-2026
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.
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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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