SHERPA NX BALANCED™ SB6AL75Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000893408), received between Sep 16, 2026 and Sep 16, 2026 — 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 16, 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.

• InjurySep 16, 2026Deformation Due to Compressive Stress; Positioning Problem

  It was reported that during a procedure via the right femoral access, difficult catheter manipulation was encountered with a 7F Sherpa catheter in the setting of vascular tortuosity. The Sherpa guide catheter was noted to be kinked under fluoroscopy. Subsequent an giography identified a right iliac/femoral spiral dissection. The patient underwent CT for concern of claudication/leg ischemia related to retrograde right femoral dissection and then underwent vascular/interventional radiology intervention with angioplasty and ri ght external iliac stenting. The patient did well and was discharged the following day. No further patient complications were reported.

  Patient problems: Ischemia; Pain; Vascular Dissection

  MAUDE report 50785213 ↗