SHERPA NX BALANCED SB7EBU30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994836571), received between Apr 6, 2020 and Apr 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2020Difficult to Insert; Deformation Due to Compressive Stress; Material Deformation; Difficult to Insert; Deformation Due to Compressive Stress; Material Deformation

  A SHERPA GUIDE CATHETER WAS USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE PROTECTIVE PACKAGE. NO RESISTANCE WAS NOTED WHILE REMOVING THE DEVICE FROM PACKAGING. THE DEVICE WAS NOT INSPECTED AFTER REMOVAL FROM PACKAGING. FORCE WAS NOT USED DURING THE INSERTION/DELIVERY OF THE DEVICE. RESISTANCE WAS FELT WHEN ATTEMPTING TO INSERT A 0.035 GUIDEWIRE THROUGH THE SHERPA. IT WAS REPORTED THAT THE DEVICE WAS KINKED BETWEEN THE SECONDARY AND PRIMARY CURVE IN THE MID TONE BLUE (AT END OF DARK BLUE AND BEGINNING OF NEXT SHADE OF BLUE. THE DEVICE WAS REMOVED WHEN THE RESISTANCE WAS FELT. THE DEVICE WAS USED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927649 ↗