Boston Scientific recalled 458 NephroMax Kits on August 5, 2025, due to contamination risk. The Encore 26 Inflation Device may allow foreign particles to enter balloon dilatation catheters. Patients must stop using the device immediately and follow recall instructions.
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
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The recalled NephroMax Kits include the following model numbers: M0062101180 and M0062101600. They were distributed worldwide.
The Encore 26 Inflation Device is integral to balloon dilation catheters. Foreign material particles can migrate into the catheter during use, posing a potential health risk.
No specific incidents reported. The risk level is classified as high due to the potential for serious complications.
Stop using the NephroMax Kit immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, call Boston Scientific at 1-800-XXX-XXXX or visit their website at www.bostonscientific.com.
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