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.
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 Encore 26 Inflation Device is part of a system used to inflate and monitor pressure in balloons during dilation procedures.
Foreign material particles could migrate from the inflation device into the catheter, potentially affecting device function.
This recall is not part of a broader industry pattern.
The recall affects medical facilities handling balloon dilation procedures and could impact patient safety and procedure timelines.
FDA enforcement page for recall Z-2536-2025 and Boston Scientific customer service.
Notification by letter; refunds or replacements to follow per manufacturer timelines.
Keep recall notice, contact logs, and any replacement communications for records.
Brand: Boston Scientific. Product: Encore 26 Inflation Device. UPNs: M0062251200, M0062251210, M0062251220, M0062251230, M0062251240, M0062251260, M0062251290, M0062251300, M0062251310, M0062251350, M0062251360, M0062251370. Quantity: 1369 units. Distribution: Worldwide. Recall date: 2025-08-05. Status: Active.
No injuries or incidents have been reported in the provided data.
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