Edge SDKM-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521581395), received between Nov 14, 2018 and Sep 6, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Break; Material Fragmentation; Break; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOCATABLE GUIDE WAS REMOVED FROM THE EXTENDED WORKING CHANNEL. MULTIPLE TRANSBRONCHIAL NEEDLE ASPIRATION BIOPSIES WERE PERFORMED. TRANSBRONCHIAL FORCEPS BIOPSIES AND BRONCHOALVEOLAR LAVAGE (BAL) FLUID WERE COLLECTED. ON SEVERAL OCCASIONS, AFTER REMOVAL OF THE FORCEPS, STRANDS WERE OBTAINED, THE ORIGIN OF WHICH WAS UNCLEAR. IT WAS NOTED THAT THE CATHETER WAS DAMAGED. INSPECTION OF THE NAVIGATIONAL SYSTEMS WORKING CHANNEL AND GUIDANCE CATHETER POST-PROCEDURE DEMONSTRATED NO LOSS OF HARDWARE INTEGRITY. ACCOUNT REMOVED DEBRIS FROM BIOPSY FORCEPS AND CONTINUED SAMPLING TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17695006 ↗
• InjuryJul 21, 2020Application Network Problem; Application Program Problem; Application Network Problem; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, TWO CASES OF MAJOR CT TO BODY DIVERGENCE BUT THE SYSTEM WAS NOT ACCURATE. THE SUPERD PORTION OF THE CASE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS AS WELL.

  Patient problems: No Code Available

  MAUDE report 10305248 ↗
• MalfunctionNov 14, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A STRING CAME OUT OF THE LUMEN OF THE CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8068845 ↗