Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.
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 used to inflate and deflate balloon dilatation catheters during interventional procedures in cardiology and peripheral interventions.
Foreign material could migrate from affected devices into the balloon catheter, potentially compromising the procedure.
This recall is not described as part of a broader industry pattern in the provided data.
Medical professionals must halt use immediately. Potential need for device replacement or additional monitoring during procedures.
Official recall notice from FDA and manufacturer communications. Contact your healthcare facility’s biomedical engineering department for identification.
Refund or replacement timing will be provided by the manufacturer; no specific window given in the data.
Document recall notice, device serial numbers, dates of procedures, and any communications with the manufacturer or hospital.
Brand: Boston Scientific. Product: Encore 26 Inflation Device. Material Numbers (UPN): H74904526011; H74904526052; M0067101140; M001151050; M001151062; M00566670. Quantity: 39,739 units. Classification: Class II. Distribution: Worldwide. Context: Interventional Cardiology and Peripheral Interventions.
No specific injuries or incidents are described in the provided data. The recall status is active with a high hazard level.
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