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NephroMax High Pressure Nephrostomy Balloon Catheter — recall 82276

Health Canada — Medical Devices · Canada · 2026-07-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
82276
Date of alert
2026-07-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/nephromax-high-pressure-nephro

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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