Edge SD180EWCTE-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521199491), received between Jun 15, 2017 and Aug 6, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Device Displays Incorrect Message; Application Program Problem; Connection Problem; Device Displays Incorrect Message; Application Program Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE USER SELECTED THE INCORRECT PATIENT INFORMATION. THE LOCATABLE GUIDE AND EXTENDED WORKING CHANNEL WERE NOT DETECTED OR RECOGNIZED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730859 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) AND SHAPE-SENSING ROBOTIC-ASSISTED BRONCHOSCOPY (SSRAB)-GUIDED CONE-BEAM COMPUTED TOMOGRAPHY CBCT. A TOTAL OF 92 PATIENTS UNDERWENT ENB-CBCT AND 93 PATIENTS UNDERWENT SSRAB-CBCT FOR BIOPSY OF PULMONARY NODULES BETWEEN JULY 2020 AND MAY 2023. SUPERDIMENSION WAS USED IN THE ENB GROUP WITH AN EXTENDED WORKING CHANNEL CATHETER. THE NEEDLE OR A COMPETITOR DEVICE WAS USED FOR FINE NEEDLE ASPIRATION, FOLLOWED BY A COMPETITOR BIOPSY FORCEPS AND CYTOLOGY BRUSH TO ACQUIRE TISSUE. ALL PATIENTS UNDERWENT ENDOBRONCHIAL ULTRASOUND (EBUS)-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION FOR MEDIASTINAL STAGING FOLLOWING NAVIGATIONAL BRONCHOSCOPY. COMPLICATIONS INCLUDED:  PNEUMOTHORAX IN 2(2.1%) PATIENTS, ONE PATIENT HAD HYPOXIC RESPIRATORY FAILURE AND TWO (2.1%) PATIENTS HAD HEMODYNAMIC INSTABILITY. INTERVENTIONS WERE NOT REPORTED. CONE-BEAM COMPUTED TOMOGRAPHY-GUIDED SHAPE-SENSING ROBOTIC BRONCHOSCOPY VS. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PULMONARY NODULES 10.21037/JTD-24-178.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax; Respiratory Failure

  MAUDE report 20801291 ↗
• InjuryAug 30, 2022Break; Application Program Problem; Break; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE EXTENDED WORKING CHANNEL (EWC) WAS BROKEN/CRACKED/DAMAGED. THE PATIENT WAS UNDER ANESTHESIA. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE, AND WAS NOT COMPLETED BY OTHER MEANS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15324236 ↗
• InjuryFeb 23, 2022Failure to Advance; Application Program Problem; Failure to Advance; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOCATABLE GUIDE (LG) DID NOT EXTEND BEYOND THE EXTENDED WORKING CHANNEL (EWC). THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13583982 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A LITERATURE ARTICLE, 32 CONSECUTIVE PATIENTS WERE PROSPECTIVELY ENROLLED TO ASSESS THE DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) COMBINED WITH TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) AND TO COMPARE IT WITH STANDARD TRANSBRONCHIAL BIOPSY (TBB) IN PULMONARY NODULES OF LESS THAN 2 CM IN DIAMETER. AFTER INSERTION OF A RIGID BRONCHOSCOPE, A GUIDE SHEATH WAS FIRST INSERTED THROUGH A FLEXIBLE BRONCHOSCOPE IN THE SEGMENTAL BRONCHUS CLOSE TO THE TARGET NODULE WITH THE PREVIOUSLY DESCRIBED ENB TECHNIQUE. IN THREE PATIENTS, THEY WERE UNABLE TO REACH THE TARGET WITH THE ENB. AS A CONSEQUENCE, THE METHOD WAS SUCCESSFUL IN 29 PATIENTS. ADVERSE EVENTS CONSISTED IN 15 MILD OR MODERATE BLEEDINGS AND ONE PNEUMOTHORAX. BLEEDING WAS GRADED 1 AND 2 IN, RESPECTIVELY, ELEVEN AND FOUR PATIENTS. PNEUMOTHORAX NEEDING PLEURAL DRAINAGE FOR THREE DAYS WAS OBSERVED IN ONE PATIENT.

  Patient problems: Blood Loss; Pneumothorax

  MAUDE report 8198896 ↗
• MalfunctionJul 17, 2018Material Fragmentation; Device Contamination with Chemical or Other Material; Material Fragmentation

  ACCORDING TO THE REPORTER, THE EXTENDED WORKING CHANNEL HAD A PLASTIC THREAD COME OUT DURING A CASE. WE FOUND ONE PIECE OF "PLASTIC THREAD" IN THE BIOPSY FORCEPS WITH A BIOPSY THAT WAS APPROXIMATELY 2 CM LONG. ONE OTHER PIECE ABOUT THE SAME SIZE WAS FOUND HANGING OUT OF THE EXTENDED WORKING CHANNEL AFTER COMPLETION OF THE CASE AND THE BRONCHOSCOPE WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693987 ↗
• MalfunctionJul 17, 2018Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation

  ACCORDING TO THE REPORTER, THE EXTENDED WORKING CHANNEL HAD A PLASTIC THREAD APPROX. 6-7 CM COME OUT DURING A CASE. A "PLASTIC THREAD" APPROXIMATELY 60CM IN LENGTH WAS FOUND HANGING OUT OF THE END OF THE EXTENDED WORKING CHANNEL FOLLOWING THE COMPLETION OF THE CASE AND THE REMOVAL OF THE BRONCHOSCOPE. THE CASE WAS COMPLETED AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7693927 ↗
• MalfunctionJun 15, 2017Material Deformation; Material Deformation

  SITE REPORTED A STRING-LIKE FIBER FROM THE EXTENDED WORKING CHANNEL CATHETER CAME OUT WHILE BIOPSYING DURING A SUPERDIMENSION ENB PROCEDURE. THE SITE REPORTED NOTHING WAS LEFT BEHIND IN THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY, DEATH, OR OTHER SERIOUS ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642854 ↗