CanadaNephroMax High Pressure Nephrostomy Balloon Catheter (catalogue numbers M0062101180, M0062101420, M0062101620, M0062101440, M0062101170, M0062101400, M0062101600, M0062101640) is affected; the renal sheath on some devices may be packaged in a reversed orientation. Boston Scientific reported that if the sheath orientation is not corrected prior to use the non‑tapered end may be inserted in the patient, increasing resistance and causing difficulty advancing, withdrawing or positioning the catheter; seven complaints were reported between November 2025 and April 2026. Contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101180
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101420
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101620
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101440
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101170
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101400
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101600
Affected products: NephroMax High Pressure Nephrostomy Balloon Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M0062101640
The hazard
Boston Scientific is notifying you that the renal sheath for certain NephroMax™ high pressure nephrostomy balloon catheters may be packaged in a reversed orientation.
Between November 2025 and April 2026, seven (7) complaints reported reversed sheath orientation upon opening. In all cases, the issue was identified and corrected prior to patient use. If the sheath orientation is not corrected prior to use, the non-tapered end may be inserted in the patient, which could increase resistance and result in difficulty advancing, withdrawing or positioning the catheter. The potential for patient harm is considered low because the issue is readily identifiable and can be corrected prior to use.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States