Official recall record
NephroMax High Pressure Nephrostomy Balloon Catheter
- Issuing authority
- Health Canada
- Alert date
- 2026-07-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Record last checked against the registry on 2026-07-12.