Edge SDK4000-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521545557), received between May 10, 2017 and Feb 18, 2025 — classified as 13 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (14 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Material Fragmentation; Problem with Sterilization; Break; Material Fragmentation; Problem with Sterilization

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PROCEDURE KIT, A FOREIGN OBJECT WAS OBSERVED NEAR THE LOCATABLE GUIDE BY THE PHYSICIAN BEFORE REGISTRATION. ADDITIONALLY, THERE WAS AN ISSUE WITH THE EXTENDED WORKING CHANNEL, WHICH WAS FOUND TO BE BROKEN, CRACKED, OR DAMAGED. THE KIT WAS REMOVED AND WIPED OFF, BUT THE PROTRUSION REMAINED, LEADING TO THE REQUEST FOR ANOTHER KIT. THE LOCATABLE GUIDE WAS NOT EXTENDED PAST THE ENDOTRACHEAL TUBE INTO THE PATIENT'S AIRWAY. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE STRING WAS CREATED FROM RADIAL GOUGE ACROSS THE INSIDE OF THE EWC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395951 ↗
• MalfunctionNov 4, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY USING A NEW CATHETER AND THE REGISTRATION PROCESS RETURN TO NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598243 ↗
• MalfunctionJul 17, 2024Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS EXCESS BLEEDING IN THE AIRWAYS DURING INITIAL REGISTRATION. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19761240 ↗
• MalfunctionJul 16, 2024Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE ON INITIAL REGISTRATION, THE CATHETER TIP MIGHT HAVE BEEN TOO SHARP CAUSING EXCESS BLEEDING WITHIN AIRWAYS. THE PHYSICIAN WAS PLUNGING TOO DEEP WITHIN AIRWAYS. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19755820 ↗
• MalfunctionDec 8, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN WAS STRUGGLING DURING REGISTRATION BECAUSE THE SYSTEM WAS SAYING THE CATHETER WAS OUTSIDE THE SENSING VOLUME. THE SURGEON CONFIRMED THAT THE PLACEMENT OF THE PATIENT TRIPLETS WAS IN THE CORRECT LOCATION. TO RESOLVE THE ISSUE, A NEW KIT WAS OPENED AND USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294495 ↗
• MalfunctionNov 17, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LINING OF CATHETER WAS STRIPPED AND COMING OUT END OF CATHETER. NO DEVICE FRAGMENT DROPPED ON PATIENT. THE PHYSICIAN HAD FINISHED THE SAMPLING AND WAS COMPLETING A BRONCHOALVEOLAR LAVAGE (BAL). THE PHYSICIAN THEN MOVED ON TO ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) AND FINISHED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165080 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN USED THE TOWER WITH A KIT, NAVIGATED TO THE TARGET AND USED RADIAL EBUS FOR CONFIRMATION THEN USED THE FOLLOWING ENDOSCOPIC TOOLS: BRUSH, FORCEPS AND SUPERTRAX NEEDLE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE, HOWEVER, THE PATIENT EXPERIENCED BLEEDING. EPINEPHRINE, SALINE AND TAMPONADE WERE USED TO RESOLVE THE BLEEDING. THE PHYSICIAN WAS ABLE TO TAMPONADE THE BIOPSY SITE WITH SCOPE TO CONTROL AND GET THE BLEEDING TO STOP. OUT OF AN ABUNDANCE OF CAUTION THE PATIENT WAS LEFT INTUBATED AND ADMITTED FOR OVERNIGHT OBSERVATION IN THE SURGICAL INTENSIVE CARE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11271950 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN ONLY TARGETED ONE SIDE OF THE LUNG WITH BIOPSY TOOLS. HOWEVER, THE PATIENT EXPERIENCED BILATERAL PNEUMOTHORAX. THE PHYSICIAN HAD TO INSERT CHEST TUBE. THIS RESULTED TO EXTENDED PATIENT HOSPITALIZATION FOR ADDITIONAL 4 DAYS.

  Patient problems: Pneumothorax

  MAUDE report 10975129 ↗
• InjuryAug 17, 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 THE PROCEDURE, THE PHYSICIAN COULD NOT GET AN ADEQUATE REGISTRATION IN ORDER TO ADVANCE TO NAVIGATION. SOMETHING SEEMED TO BE INTERFERING WITH THE MAGNETIC FIELD. DID ALL OF THE PROPER TROUBLE SHOOTING AND CONTINUED TO HAVE THE SAME FAILED RESULT. REGISTRATION REVIEW NEVER SHOWED THE DATA POINTS WITHIN THE 3D TREE. FINALLY, A NURSE MENTIONED THAT THE PATIENT HAD LOTS OF METAL IN THE NECK AND SPINE. DID A FLUORO SHOT AND CONFIRMED THAT THERE WERE MULTIPLE METAL RODS IN THE PATIENT'S NECK AND UPPER SPINE. THE PROCEDURE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10417993 ↗
• MalfunctionMay 15, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE THE CUSTOMER REPORTED A LONG PIECE OF STRING FOUND INSIDE THE EXTENDED WORKING CHANNEL. IT WAS REMOVED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061934 ↗
• MalfunctionMar 8, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE A HAIRLIKE ITEM CAME OUT WITH THE BIOPSY FORCEPS SPECIMEN. IT LOOKED GRAYISH-WHITISH AND LONG. THE TISSUE SPECIMEN WAS ATTACHED TO THE HAIRLIKE ITEM ON BOTH ENDS. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803995 ↗
• MalfunctionNov 26, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PLASTIC STRING COMING UNDONE FROM THE INSIDE OF THE WORKING CHANNEL. THE SUPERD PORTION OF THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378282 ↗
• MalfunctionJun 14, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING THE SAMPLING IN A PROCEDURE, POSSIBLE SHAVINGS OR PARTS OF CATHETER PULLED OUT FROM CATHETER WITH SAMPLE FROM PATIENT. THE LONG STRING PIECES THAT WERE CLEAR IN COLOR. PULLED A TOTAL OF 3-4 PIECES OUT WITH SAMPLES FROM PATIENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE IS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8702101 ↗
• MalfunctionMay 29, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON REMOVAL OF THE SPECIMEN FROM THE CATHETER, THERE APPEARED TO BE A THIN LINE OF PLASTIC THAT SEPARATED OR SLICED FROM THE 180 CATHETER AND CAME OUT ALONG WITH THE SPECIMEN (APPROX. 53CM). THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 8649705 ↗
• InjuryMay 28, 2019Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE WHEN REVIEWING THE REGISTRATION PICTURE, THE DATA POINTS WERE SCATTERED. THE PHYSICIAN ATTEMPTED 4 TIMES AND HE COULD NOT PROPERLY COMPLETE REGISTRATION. THEY WERE UNSURE IF THERE WAS AN ISSUE WITH THE LOCATABLE GUIDE ISSUE OR SOMETHING ELSE. THEY REBOOTED THE SYSTEM HOWEVER THEY DID NOT TRY REPLACING ANY OF THE CABLES OR THE LOCATABLE GUIDE. THE PHYSICIAN CANCELLED THE CASE AND DID NOT NOT COMPLETED IT BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 8645383 ↗
• InjuryMay 22, 2019Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER DURING THE REGISTRATION REVIEW IN A PROCEDURE, THE DATA POINTS WERE SCATTERED. ALSO, AFTER INSERTING THE LOCATABLE GUIDE INTO THE TRACHEA AND ABOUT TO GO TO THE RIGHT UPPER LOBE, THE CHECK MARKS FOR BOTH UPPER AND LOWER LOBES IMMEDIATELY POPULATED. THE DOCTOR SAID THAT HE CONTINUED AS HE USUALLY WOULD WITH HIS REGISTRATION AND IT WAS ACTING "FUNNY" AND THE DATA POINTS WERE REALLY OFF. THE PATIENT IS UNDER GENERAL ANESTHESIA. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8634041 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, A SMALL PNEUMOTHORAX WAS DISCOVERED. NO CHEST TUBE NEEDED AND PATIENT RELEASED THE SAME DAY AS PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 8627438 ↗
• InjuryApr 26, 2019Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD LOBECTOMY AND IT TOOK A LONG TIME FOR THE AREA TO CHECK OFF IN REGISTRATION. DID ALL TO GET THE LESION AND SAMPLED ENTIRE AREA TO SEE IF WAS IN TUMOR TO PLACE FIDUCIALS. THE NODULE WAS PET POSITIVE SO AFTER AN HOUR OF SAMPLING DIDN'T PLACE FIDUCIALS BECAUSE OF NO CONFIRMATION. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE SUPERD CASE WAS NOT COMPLETED AND THE CASE WAS NOT COMPLETED BY OTHER MEANS.

  Patient problems: No Code Available

  MAUDE report 8558396 ↗
• MalfunctionApr 24, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHILE USING A FORCEPS, A PLASTIC SUBSTANCE WAS NOTICED COMING OUT OF THE EXTENDED WORKING CHANNEL. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546114 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER A PNEUMOTHORAX WAS DISCOVERED AFTER THE CASE. THEY WERE NOT SURE WHICH DEVICE CAUSED THE EVENT. THE PATIENT IS STILL ADMITTED IN THE HOSPITAL.

  Patient problems: No Code Available; Pneumothorax

  MAUDE report 8501264 ↗
• MalfunctionDec 12, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON REMOVAL OF THE FORCEP AND CATHETER, STRIPS OF THE BLUE PLASTIC, MATCHING COLOR OF THE EXTENDED WORKING CHANNEL WERE NOTICED. FORCEP USED - OLYMPUS MODEL FB-211D. THE CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156929 ↗
• InjuryNov 12, 2018Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD A PNEUMOTHORAX. DURING THE PROCEDURE THE CATHETER WAS VERY DIFFICULT TO TELESCOPE IN AND OUT, AND THE PHYSICIAN SWITCHED THE CATHETER OUT MID PROCEDURE. AFTER THE PROCEDURE THE PATIENT WAS MOVED TO POST OP AND HAD CHEST X-RAY. A PNEUMOTHORAX OF THE LEFT LUNG WAS DETECTED. THE PATIENT RECEIVED CHEST TUBE AND WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 8061570 ↗
• MalfunctionSep 25, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, HAIR LIKE PLASTIC CAME OUT OF THE EXTENDED WORKING CHANNEL CATHETER ANYTIME SOMETHING WAS INTRODUCED INTO THE CATHETER, SUCH AS THE LOCATABLE GUIDE OR BIOPSY TOOL. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907393 ↗
• MalfunctionSep 13, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE OF BOTH ENDOBRONCHIAL PROCEDURE KITS APPEARED TO MALFUNCTION. A THIN LINE OF PLASTIC BECOME SEPARATED OR SLICED FROM THE 180 CATHETER DURING OR AFTER THE PROCEDURE BY USE OF ADDITIONAL TOOLS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872755 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PROCEDURE, THE PATIENT EXPERIENCED PNEUMOTHORAX AFTER PROCEDURE HAD BEEN COMPLETED. THE PATIENT REQUIRED A CHEST TUBE.

  Patient problems: Pneumothorax

  MAUDE report 7868838 ↗