Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)
Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.


