Boston Scientific recalled 1,369 UroMax Ultra Kits on August 5, 2025. Foreign particles may migrate from the Encore 26 Inflation Device into balloon dilation catheters. Patients and healthcare providers must stop using the device immediately.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
The recall affects UroMax Ultra Kits with material numbers M0062251200 to M0062251370. These devices have been distributed worldwide.
The Encore 26 Inflation Device can allow foreign material particles to enter balloon dilation catheters. This contamination poses a high risk to patients during procedures.
No specific injury incidents have been reported. However, the contamination risk is classified as high.
Stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions and follow the recall guidelines.
For more information, visit Boston Scientific's recall page or contact them directly through their customer service.
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