Health Canada — Medical Devices · Canada · 2025-08-14 · Type II
As described by Health Canada — Medical Devices: Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: 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
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.