SHERPA NX BALANCED SB7AL10SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994836816), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 injury.

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.

• InjuryAug 26, 2019Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; 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 PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE CATHETER WAS QUICKLY KINKED FROM THE PRIMARY CURVE. THE KINK OCCURRED WHILE THE DEVICE WAS IN THE PATIENT. NO PATIENT INJURY REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED A FLEXURAL KINK WITH WIRE BRAID EXPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929290 ↗