Recall MonitorHealth Products
Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology, Health products - Medical devices - Cardiovascular
Product: Encore™ 26 Inflation Device, Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| UroMax Ultra™ Balloon Dilatation Catheter | More than 50 numbers, contact manufacturer. | M0062251230 |
| UroMax Ultra™ Balloon Dilatation Catheter | More than 50 numbers, contact manufacturer. | M0062251260 |
| UroMax Ultra™ Balloon Dilatation Catheter | More than 50 numbers, contact manufacturer. | M0062251200 |
| UroMax Ultra™ Balloon Dilatation Catheter | More than 50 numbers, contact manufacturer. | M0062251210 |
| Encore™ 26 Inflation Device | More than 50 numbers, contact manufacturer. | M0067101140 |
| Encore™ 26 Inflation Device | More than 50 numbers, contact manufacturer. | M001151062 |
| Encore™ 26 Inflation Device | More than 50 numbers, contact manufacturer. | M001151050 |
| Encore™ 26 Inflation Device | More than 50 numbers, contact manufacturer. | M00566670 |
| Encore™ 26 Advantage Kit | More than 50 numbers, contact manufacturer. | H74904527011 |
| Encore™ 26 Advantage Kit | More than 50 numbers, contact manufacturer. | H74904527052 |
| NephroMax™ High Pressure Nephrostomy Balloon Catheter | More than 50 numbers, contact manufacturer. | M0062101180 |
| NephroMax™ High Pressure Nephrostomy Balloon Catheter | More than 50 numbers, contact manufacturer. | M0062101600 |
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