NephroMax High Pressure Nephrostomy Balloon Catheter

Issue

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.