Edge SD300LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521199514), received between Mar 6, 2017 and Aug 6, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (5 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 10 most recent of 10 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 22730812 ↗
• InjuryNov 14, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOCATABLE GUIDE (LG) DEVICE WAS NOT DETECTED. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE AND WAS COMPLETED BY OTHER MEANS. IT WAS ALSO NOTED THAT THE PATIENT HAD TEMPORARY INJURY AS THERE WAS A PROLONGED ANESTHESIA TIME.

  Patient problems: Oversedation

  MAUDE report 15791080 ↗
• 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 13583948 ↗
• InjuryJan 11, 2021Application Program Problem; Connection Problem; Application Program Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE LG WAS NOT DETECTED OR RECOGNIZED. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ENB PORTION OF THE CASE AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

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

  MAUDE report 11146869 ↗
• InjuryJan 7, 2021Application Program Problem; Connection Problem; Application Program Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE LG WAS NOT DETECTED OR RECOGNIZED. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ENB PORTION OF THE CASE AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

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

  MAUDE report 11132601 ↗
• InjurySep 16, 2020Device Displays Incorrect Message; Application Program Problem; Patient Data Problem; Device Displays Incorrect Message; Application Program Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN TRIED MANY DIFFERENT THINGS TO GET IT TO WORK AND NEVER DID. THE PHYSICIAN THEN SWITCHED BACK TO THE OLD LG THAT DID NOT INDICATE OUT OF SENSING VOLUME BUT UNFORTUNATELY THE PHYSICIAN WAS UNABLE TO REGISTER THE CASE DUE TO BAD SCAN. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ENB PORTION OF THE CASE AND WAS NOT COMPLETED BY OTHER MEANS.

  Patient problems: No Code Available

  MAUDE report 10539291 ↗
• InjuryMar 6, 2019Device Displays Incorrect Message; Patient Data Problem; Device Displays Incorrect Message; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DOCTOR TRIED REGISTERING THE LOCATABLE GUIDE, AS HE WAS GETTING CHECKMARKS ON THE RIGHT SIDE AND SWITCHED TO REGISTER THE LEFT, AN ERROR MESSAGE "YOU ARE OUTSIDE OF THE SENSING VOLUME" APPEARED. RE-REGISTER ON THE SECOND TIME BUT SAME THING HAPPENED. TRIED THE THIRD TIME TO CHECK IF THE DOCTOR WAS PULLING THE SCOPE BACK TOO FAR, BUT HE WASN'T. OPENED A NEW LOCATABLE GUIDE FROM ANOTHER KIT AND IT WORKED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE PHYSICIAN QUIT/GAVE UP. THE PROCEDURE WAS NOT COMPLETED BY OTHERS MEANS.

  Patient problems: No Code Available

  MAUDE report 8395830 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEW PER FOGELFELD, K., ET AL. (2018). "CEREBRAL ARTERY GAS EMBOLISM FOLLOWING NAVIGATIONAL BRONCHOSCOPY." JOURNAL OF INTENSIVE CARE MEDICINE, JANUARY 22,2018. A (B)(6) MALE PATIENT DEVELOPED A CEREBRAL ARTERY GAS EMBOLISM (CAGE). ONE HOUR AFTER AN ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PROCEDURE. THE PATIENT HAD INCREASING CONFUSION WITH LEFT ARM MYOCLONUS AND RIGHT UPPER EXTREMITY TWITCHING, A LEFT GAZE PREFERENCE, AND POSSIBLY LEFT FACIAL DROOP. HE WAS LETHARGIC, BUT ABLE TO MOVE ALL EXTREMITIES, AND RESPONDED TO QUESTIONS WITH HIS NAME, BUT HAD NO OTHER VERBAL OUTPUT. A CT OF THE HEAD REVEALED 2 LOW-DENSITY FOCI IN THE RIGHT HEMISPHERE SUGGESTIVE OF AIR EMBOLISM. HE WAS GIVEN LABETALOL, LORAZEPAM WITH CESSATION OF SEIZURE ACTIVITY, HOWEVER BECAME BRADYCARDIC WITHOUT A PALPABLE PULSE. ADVANCED CARDIAC LIFE SUPPORT WAS STARTED, AND HIS PULSE RETURNED. HEMODYNAMICS WERE NORMAL AND HE WAS INTUBATED AND PLACED ON OXYGEN. A BRAIN MAGNETIC RESONANCE IMAGING (MRI) REVEALED RIGHT CEREBRAL HEMISPHERE GYRIFORM CORTICAL EDEMA. THERE WAS NO EVIDENCE OF AIR EMBOLI SM ON THE MRI. HE WAS EMERGENTLY TRANSFERRED TO A FACILITY WITH A HYPERBARIC OXYGEN CHAMBER AND UNDERWENT 2

  Patient problems: Air Embolism

  MAUDE report 7602407 ↗
• MalfunctionNov 2, 2017Detachment Of Device Component; Unstable; Detachment Of Device Component; Unstable

  THE LOCATABLE GUIDE WAS RETURNED WITH ANOTHER DEVICE FOR ANALYSIS AND THE LOCATABLE GUIDE WAS FOUND WITH THE SENSOR TIP DETACHED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY, DEATH, OR OTHER SERIOUS ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995855 ↗
• MalfunctionMar 6, 2017Detachment Of Device Component; Detachment Of Device Component

  SITE REPORTED THE TIP OF THE LOCATABLE GUIDE SENSOR CATHETER DETACHED DURING A SUPERDIMENSION ENB PROCEDURE. ISSUE OCCURRED PRIOR TO THE TIP ENTERING THE PATIENT AND THERE WAS NO REPORT OF PATIENT INJURY, DEATH, OR OTHER SERIOUS ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6380624 ↗