ev3 Inc is recalling 5,189 units of the Medtronic NanoCross Elite PTA catheter because the device's balloon may fail to deflate or be difficult to deflate during use. This recall affects 20 different model sizes distributed worldwide. No injuries have been reported in this notice, but the company is voluntarily initiating this action to address the potential failure.
If the balloon fails to deflate while inside a patient's blood vessel, it can obstruct blood flow or cause damage to the vessel wall. This defect may result in the need for additional medical or surgical procedures to remove the device from the patient.
Serial number B740725 is associated with both UDI/DI 00763000758059 and 04987742337891.
Serial number B755679 is associated with both UDI/DI 00763000758066 and 04987742337907.
Serial number B760301 is associated with both UDI/DI 00763000758172 and 04987742337815.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.