Boston Scientific Corporation is recalling 109,913 Encore 26 Inflation Devices and various procedural kits, including the Encore Advantage, NephroMax, and UroMax Ultra kits. An internal investigation found that foreign material particles could migrate from these inflation devices into balloon dilation catheters during use. These devices are typically used in interventional cardiology, peripheral interventions, and urology procedures to monitor pressure and deflate balloons.
If foreign material particles migrate into the catheter and enter a patient's body during a procedure, it could lead to serious medical complications or internal injury. While no specific injuries were mentioned in the recall notice, the presence of foreign material in a medical device poses an inherent risk to patient safety.
Recall #: Z-2533-2025
Recall #: Z-2534-2025
Recall #: Z-2535-2025
Recall #: Z-2536-2025
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.