EchoTip G52011Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002520110), received between Jun 8, 2017 and Jul 22, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DURING A BRONCHOSCOPY PROCEDURE WITH NEEDLE SUCTION OF THE LIMPH NODE, THE NEEDLE BROKE, AND A FRAGMENT REMAINED IN THE AIRWAYS. IT WAS REMOVED WITH A CLIP. AS PER CUSTOMER COMPLAINT FORM: "DURING THE BRONCOSCOPY PROCEDURE WITH NEEDLE, THE NEEDLE BROKE AND REMAINED IN THE PATIENT AIRWAY, IT WAS REMOVED WITH FORCEPS."

  Patient problems: Foreign Body In Patient

  MAUDE report 22564149 ↗
• MalfunctionMar 30, 2022Material Fragmentation

  PATIENT WAS HAVING AN EBUS PROCEDURE DONE IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA, INTUBATED. SEVERAL PASSES HAD BEEN DONE ON THE SAME LYMPH NODE USING THE EBUS NEEDLE. WITH THE LAST PASS USING THIS NEEDLE, REMOVAL OF THE NEEDLE THROUGH THE SCOPE MET MUCH RESISTANCE. ASSISTING RT WITHDREW THE NEEDLE AND UPON EXAMINATION IT APPEARED THAT PART OF THE NEEDLE HAD BROKEN OFF. PHYSICIAN USED THE BRONCHOSCOPE TO EXAMINE ALL AREAS THAT ARE VISIBLE USING THE SCOPE AND NO NEEDLE WAS OBSERVED. PROCEDURE WAS CONTINUED USING ANOTHER NEEDLE AND OTHER INSTRUMENTS INCLUDING FLUOROSCOPY. PHYSICIAN HAD THE TECH DO A FULL FLUORO SCAN OF THE LUNGS AND NO NEEDLE WAS OBSERVED. THERE WAS NO BLEEDING UPON COMPLETION OF THE PROCEDURE. AFTER EXTUBATION AND WHILE IN RECOVERY, THE PATIENT WAS COUGHING UP BLOOD TINGED SPUTUM. PACU RN NOTED A METAL OBJECT ON HIS LIP. PULMONOLOGIST AND ANESTHESIA AWARE. REPEAT CXR COMPLETED- NO NEEDLE NOTED. FAIR LEVEL OF CONFIDENCE THAT REMAINDER OF NEEDLE WAS COUGHED OUT. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13966173 ↗
• InjuryJan 6, 2020Break; Break

  THE NEEDLE BROKE INSIDE THE PATIENT DURING THE SURGERY. "AS PER COMPLAINT FORM": THE DOCTOR WAS ENTERING THE STATION 10R. AT THE SECOND PUNCTURE THEY VERIFIED THAT THE NEEDLE BROKE AND WAS VISIBLE AT THE ENTRANCE OF THE MAIN BRONCHUS OF LEFT. THE PATIENT UNDERWENT AN RX AND A CT SCAN AND THE NEEDLE WAS IDENTIFIED IN THE BRONCHIAL TREE. TRANSLATION RECEIVED 12-DEC-2019: EXAM EXECUTED WITH DEDICATED INSTRUMENT FOR EBUS TBNA, ROUND SHAPE LYMPH NODES VISUALIZED WITH DIAMETER OVER 1 CM IN STATION 4R AND 10R EXECUTED TBNA IN THESE STATIONS. DURING THE PROCEDURE IN A SECOND ATTEMPT IN STATION 10R WE VERIFIED THE RUPTURE OF COOK 22 G NEEDLE. THE FRAGMENT OF NEEDLE (AROUND 2 CM) IS THEN VISUALIZED IN THE ENTRY OF THE LEFT MAIN BRONCHUS FOR AN INSTANT THEN IS NO MORE VISIBLE IN THE BRONCHIAL TREE. THE PATIENT UNDERGO AN RX EXAM AND THEN TO A TAC THORAX (CT SCAN?). THE NEEDLE PORTION INITIALLY IS DETECTED IN THE ESOPHAGUS (MAYBE EXPELLED BY THE PATIENT WITH COUGH AND THEN INGESTED) AND THEN DURING A SECOND CT SCAN, VISUALIZED IN THE STOMACH. DR (B)(6) EXECUTE A EGDS AND REMOVED THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9553400 ↗
• MalfunctionJan 6, 2020Use of Device Problem; Use of Device Problem

  THEY TRIED TO PUSH THE NEEDLE A FEW TIMES MORE. IN THIS CASE NEEDLE HAS BEEN WARPED. THAN THEY DECIDED TO OPENED NEW PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552469 ↗
• InjuryDec 24, 2019Break; Break

  NEEDLE'S FRACTURING DURING THE PROCEDURE, IF THE NEEDLE NEEDS TO PASS FROM HARD CARTILAGE TO REACH THE TISSUE, NEEDLE SHAPE CAN CHANGE. ESPECIALLY, ASPIRATION MOMENT IS MOST IMPORTANT TO AVOID THE NEEDLE FRACTURING. BECAUSE NITINOL STYLET SUPPORT THE LUMEN FOR THE FIRST PUNCHING BUT ASPIRATION MOMENT, UNFORTUNATELY LUMEN STAYS EMPTY. IN THIS CASE, YOU CAN FRACTURE THE NEEDLE EASY. EVERY PROBLEM MAY BE ABOUT USING, BUT SUCH A FRACTURE PROBLEM, I CANNOT SAY ANYTHING TO SOLVE THIS PROBLEM. AS PER COMPLAINT FORM: " NEEDLE HAS BEEN PULL IT OUT FIRST. FRACTURED NEEDLE PART HAS BEEN TAKEN WITH FORCEPS."

  Patient problems: Foreign Body In Patient

  MAUDE report 9516356 ↗
• MalfunctionDec 16, 2019Break; Fracture; Improper or Incorrect Procedure or Method; Break; Fracture; Improper or Incorrect Procedure or Method

  THEY INFORMED ME THAT THE DOCTOR PERFORMED THE FIRST ATTEMPT AND THE NEEDLE SEEMED GOOD BUT WHEN THEY LOOKED AT IT WITH THE ENDOSCOPE, THE IMAGE SHOWED THAT THE TIP WAS SLIGHTLY BENT. THEY TRIED TO TAKE IT OUT FROM THE PATIENT AND WHEN THEY PLACED IT ON THE STERILE TABLE, THE TIP BROKE IMMEDIATELY. THE BROKEN PART IS BEING RETURNED ALONG WITH THE NEEDLE ITSELF IN ITS ORIGINAL BOX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9472222 ↗
• MalfunctionAug 21, 2019Retraction Problem; Retraction Problem

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. INITIAL REPORT DETAILS: USER CHECK THE DEVICE FUNCTION BEFORE USE WHEN FOUND OUT THE NEEDLE IS DIFFICULT TO PULL OUT. AFTER THE NEEDLE WAS PULL OUT , IT CANNOT BE RETRACTED AFTERWARD. NO USE ON PATIENT. ADDITIONAL INFORMATION PROVIDED ON 06-SEP-19 INDICATED THAT IT IS STYLET WHICH WAS DIFFICULT TO PULL OUT AND NOT THE NEEDLE. BASED ON REVIEW OF ADDITIONAL INFORMATION PROVIDED AND THE COMPLETED INVESTIGATION THIS COMPLAINT NO LONGER MEETS THE FDA MDR REPORTING CRITERIA OF A MALFUNCTION OR SERIOUS INJURY REPORT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8915484 ↗
• MalfunctionSep 4, 2018Break; Break

  NEEDLE BROKE OFF DURING PROCEDURE. ACTION TAKEN: BIOPSY FORCEPS USED TO RETRIEVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7842623 ↗
• MalfunctionJul 3, 2018Kinked; Retraction Problem; Material Deformation; Kinked; Retraction Problem; Material Deformation

  ¿WE USED AN EBUS NEEDLE THIS MORNING WHICH BENT DURING THE PROCEDURE AND WE WERE UNABLE TO PULL IT BACK THROUGH THE SCOPE SO PULLED THE WHOLE SCOPE OUT WITH NEEDLE BENT, THROUGH THE MOUTH. WHEN WE LOOKED AT THE NEEDLE IT WAS VERY WEAK AT THE POINT WHERE IT BENT (2CM FROM TIP) AND I THINK IF WE'D TRIED HARDER TO PULL IT OUT IT WOULD HAVE SNAPPED IN THE TRACHEA. WE HAVE SAVED THE NEEDLE, WOULD YOU LIKE US TO SEND IT BACK?¿ "AS PER COMPLAINT FORM": WE USED AN EBUS NEEDLE THIS MORNING WHICH BENT DURING THE PROCEDURE AND WE WERE UNABLE TO PULL IT BACK THROUGH THE SCOPE SO PULLED THE WHOLE SCOPE OUT WITH NEEDLE BENT, THROUGH THE MOUTH. WHEN WE LOOKED AT THE NEEDLE IT WAS VERY WEAK AT THE POINT WHERE IT BENT (2CM FROM TIP) AND I THINK IF WE'D TRIED HARDER TO PULL IT OUT IT WOULD HAVE SNAPPED IN THE TRACHEA. 1ST PASS SAMPLE ACQUIRED USING NEEDLE. QUITE DIFFICULT TO GET NEEDLE THROUGH TRACHEAL WALL. 2ND PASS NEEDLE DID NOT EASILY PASS THROUGH TRACHEAL WALL AND I INSTRUCTED SPR WHO WAS HOLDING THE SCOPE TO GENTLY ADVANCE THE SCOPE INTO THE PATIENT TO APPLY ADDITIONAL PRESSURE. STILL UNABLE TO GET NEEDLE INTO NODE THEREFORE ATTEMPTED TO WITHDRAW NEEDLE FROM TRACHEAL WALL, CLEAR THAT IT WAS BE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657612 ↗
• MalfunctionMay 18, 2018Retraction Problem; Retraction Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMATION THAT THE NEEDLE WAS NOT FULLY RETRACTED PRIOR TO PATIENT REMOVAL. DURING EBUS PROCEDURE, TUMOR WAS LOCATED BY ULTRASONIC LOCALIZATION. USER TRY TO DO BIOPSY WITH ECHO-HD-22-EBUS-O BUT FOUND OUT THE CORE NEEDLE WAS VERY DIFFICULT TO PULL OUT AND RETRIEVE BACK TO ULTRASOUND NEEDLE. USER WITHDRAW THE DEVICE FROM EBUS AND DETECTED A BENDING 10CM FROM OUTER SHEATH WHICH CAUSE THE DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7524987 ↗
• MalfunctionApr 30, 2018Kinked; Material Perforation; Kinked; Material Perforation

  THE NEEDLE AND SHEATH "SEPARATED" AFTER FIRST "ATTEMPT" WHICH AFFECTED SECOND BIOPSY. OPERATOR CHANGED ANOTHER SAME PRODUCT TO FINISH THE BIOPSY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472137 ↗
• MalfunctionMar 22, 2018Kinked; Kinked

  REP ADVISED THAT THE STILLED WOULD RUN THROUGH THE DEVICE AFTER THEIR FIRST PASS. "AS PER COMPLAINT FORM": FIRST PASS SUCCESSFUL HOWEVER STYLET WOULD NOT ENTER BACK INTO THE BORE OF THE NEEDLE AGAIN.

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

  MAUDE report 7360876 ↗
• MalfunctionFeb 14, 2018Bent; Kinked; Bent; Kinked

  REPORTED AS - DIFFICULTY TO GET OUT THE SHEATH DESPITE MANY ATTEMPTS AND THE PROCEDURE WAS ABORTED. LAB EVALUATION CONDUCTED ON THE 19 JAN 2018 DISCOVERED THE NEEDLE WAS KINKED PROXIMALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270098 ↗
• MalfunctionDec 27, 2017Bent; Kinked; Bent; Kinked

  PRODUCT DID NOT WORK AS EXPECTED. REP DOESN'T HAVE FURTHER INFO. PRODUCT AVAILABLE IN PURCHASING DEPT. "AS PER COMPLAINT FORM": CUSTOMER OPENED THE PACKAGE. REMOVED THE SYSTEM (EBUS NEEDLE) OUT OF THE PACKAGE. HE TRIED TO MOVE THE SLIDING SHEATH ADJUSTER IN-FRONT OF THE ENDOSCOPE. BUT IT'S NOT WORKING, THE SHEATH ADJUSTER STUCK AT THE SYSTEM. AFTER THIS HE TRIED TO REMOVE THE STYLET. BUT IT WASN'T POSSIBLE.HE PULLED HARDER, WITHOUT SUCCESS. AFTER THE THIRD TRY THE STYLET CAME OUT OF THE SYSTEM AND WAS COMPLETELY DESTROYED. THE CUSTOMER USED A NEW COOK SET WITH THE SAME LOT NUMBER AND THE PRODUCT WORKS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147532 ↗
• MalfunctionJun 8, 2017Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: " ON THE THIRD PASS OF THE NEEDLES THEY BENT. THE PHYSICIAN HAD A QUANTITY OF 3 NEEDLES OF THE SAME LOT NUMBER BEND. A FOURTH NEEDLE WAS USED AND WORKED AS INTENDED. THERE WAS NO HARM TO THE PATIENT." UPON EVALUATION TWO FAILURE MODES WERE DISCOVERED: NEEDLE KINK/BENT AND NEEDLE BROKE [3001845648-2017-00210] (B)(4). PER THE DISTRICT MANAGER: "THE CUSTOMER REPLIED THAT THEY WEREN¿T SURE WHEN THE NEEDLE BROKE, BUT ASSUMED IT WAS DURING BIOPSY. THEY STATED THAT THE NEEDLE TIP CAME OUT OF THE SCOPE DURING CLEANING. THE SCOPE DID NOT PASS THE LEAK TEST AND HAD TO BE SENT OUT FOR REPAIR. THEY ALSO STATED THERE WAS NO PATIENT HARM OR PIECES THAT NEEDED TO BE RETRIEVED WHILE INSIDE THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6621254 ↗