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Encore™ 26 inflation device, encore™ 26 advantage kits, nephromax™ kits and uromax ultra™ kits
Official notice
14 Aug 2025
An official Health Canada notice concerns Encore™ 26 inflation device, encore™ 26 advantage kits, nephromax™ kits and uromax ultra™ kits. Boston Scientific is initiating a removal of certain batches of the Encore™ 26 Inflation Device and certain batches of Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits in which the impacted Encore™ 26 inflation devices are a component due to the potential presence of foreign material. 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. Recall start date: August 5, 2025 Published 2025-08-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77906
Official notice
2025-08-14
The hazard
The hazard
Boston Scientific is initiating a removal of certain batches of the Encore™ 26 Inflation Device and certain batches of Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits in which the impacted Encore™ 26 inflation devices are a component due to the potential presence of foreign material. 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. Recall start date: August 5, 2025
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Turn on recall alertsAffected products
Affected products
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Product 6
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Product 8
Product 9
Product 10
Product 11
Product 12
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
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Phone
Brand: Boston Scientific, Encore™ 26 Inflation Device Encore™ 26 Advantage Kits Nephromax™ Kits And Uromax Ultra™ Kits.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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