Boston Scientific recalled 39,739 Encore 26 Inflation Devices on August 5, 2025. Foreign particles may migrate into balloon dilation catheters during use. 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
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The recalled devices include model numbers H74904526011, H74904526052, M0067101140, M001151050, M001151062, and M00566670. These devices were distributed worldwide.
An internal investigation revealed that foreign material particles can migrate from the Encore 26 Inflation Device into the balloon dilation catheter. This poses a high risk during medical procedures.
No specific incidents or injuries have been reported at this time. The recall is precautionary due to potential contamination.
Stop using the Encore 26 Inflation Device immediately. Follow the recall instructions from Boston Scientific and contact your healthcare provider for guidance.
For more information, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2533-2025.
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