Official recall record

Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits

Health Canada — Medical Devices · 2025-08-14 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-08-14
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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