SHERPA NX BALANCED SB7EBU375SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994837547), received between Aug 28, 2019 and Aug 30, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2019Material Deformation; Material Deformation

  A SHERPA GUIDE CATHETER WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS PREPPED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE CATHETER QUICKLY KINKED AT THE PRIMARY CURVE WHEN THE GUIDE LINER WAS BEING PASSED THROUGH THE SHERPA. NO PATIENT INJURY REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WIRE BRAID WAS EXPOSED AT THE PROXIMAL SIDE HOLE AND THE SEGMENT MATERIAL WAS SPLIT ON BOTH SIDES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8948769 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE A 7F SHERPA BALANCED GUIDE CATHETER WAS USED TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE CATHETER WAS KINKED FROM THE PRIMARY CURVE WHILE IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY. ANALYSIS ON THE RETURNED DEVICE FOUND THAT THE DEVICE WIRE BRAID WAS EXPOSED AT THE PROXIMAL SIDE HOLE WITH SEGMENT MATERIAL SPLIT ON ONE SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8938736 ↗