Covidien LP is recalling 16,336 units of various sizes of the Chameleon PTA Balloon Catheter with Injection Port because specific lots failed internal balloon pressure testing. These catheters are used to open blocked or narrowed blood vessels, and a pressure failure during a procedure could lead to significant complications for the patient. The recall affects several models ranging in size from 5mm to 12mm that were distributed nationwide in the United States and internationally. Covidien has initiated this voluntary recall by sending notification letters to affected customers to prevent further use of the defective devices.
If the balloon fails to maintain or meet specified pressure levels during a medical procedure, it could burst or fail to properly dilate the blood vessel, potentially requiring additional surgical intervention or causing internal injury to the patient. While the firm has initiated a voluntary recall, any device failure during a vascular procedure poses a moderate risk of harm.
Quarantine and return affected products to manufacturer.
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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