Public recall detail

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

2025-08-14

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Recall Safety notice
Quick summary

Quick summary: Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits. Date: 2025-08-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits. Date: 2025-08-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBOSTON SCIENTIFIC CORPORATION
ProductEncore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77906

Affected products

ProductUroMax Ultra™ Balloon Dilatation Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062251230
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionUroMax Ultra™ Balloon Dilatation Catheter
ProductUroMax Ultra™ Balloon Dilatation Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062251260
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionUroMax Ultra™ Balloon Dilatation Catheter
ProductUroMax Ultra™ Balloon Dilatation Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062251200
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionUroMax Ultra™ Balloon Dilatation Catheter
ProductUroMax Ultra™ Balloon Dilatation Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062251210
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionUroMax Ultra™ Balloon Dilatation Catheter
ProductEncore™ 26 Inflation Device
LotMore than 50 numbers, contact manufacturer.
ModelM0067101140
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Inflation Device
ProductEncore™ 26 Inflation Device
LotMore than 50 numbers, contact manufacturer.
ModelM001151062
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Inflation Device
ProductEncore™ 26 Inflation Device
LotMore than 50 numbers, contact manufacturer.
ModelM001151050
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Inflation Device
ProductEncore™ 26 Inflation Device
LotMore than 50 numbers, contact manufacturer.
ModelM00566670
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Inflation Device
ProductEncore™ 26 Advantage Kit
LotMore than 50 numbers, contact manufacturer.
ModelH74904527011
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Advantage Kit
ProductEncore™ 26 Advantage Kit
LotMore than 50 numbers, contact manufacturer.
ModelH74904527052
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionEncore™ 26 Advantage Kit
ProductNephroMax™ High Pressure Nephrostomy Balloon Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062101180
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionNephroMax™ High Pressure Nephrostomy Balloon Catheter
ProductNephroMax™ High Pressure Nephrostomy Balloon Catheter
LotMore than 50 numbers, contact manufacturer.
ModelM0062101600
Serial numberMore than 50 numbers, contact manufacturer.
DescriptionNephroMax™ High Pressure Nephrostomy Balloon Catheter

Issue

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 you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - Cardiovascular
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77906
Background{}
CompaniesBoston Scientific Corporation 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2025-08-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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