EchoTipRecalls & reported problems across all models

We found 7 models of EchoTip by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 171 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Aug 28, 2025 — classified as 24 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Break” (69 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EchoTip recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 1, 2024Open, Classified

   Devices may contain elevated levels of bacterial endotoxin.

   Z-1833-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Apr 1, 2024Open, Classified

   Devices may contain elevated levels of bacterial endotoxin.

   Z-1832-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported EchoTip problems

EchoTip models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EchoTip G31520

  Biopsy needle
  1 recall84 reports
• EchoTip G52012

  Biopsy needle
  1 recall18 reports
• EchoTip G31519

  Biopsy needle
  22 reports
• EchoTip G53408

  Biopsy needle
  22 reports
• EchoTip G52011

  Biopsy needle
  15 reports
• EchoTip G31518

  Biopsy needle
  7 reports
• EchoTip G24062

  Biopsy needle
  3 reports

Recent EchoTip adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

  NEEDLE COULDN'T BE EXTENDED. "AS PER CC FORM": THE NEEDLE-SYSTEM WAS PUSHED THROUGH THE EUS-DEVICE UNTIL THE SHEATH-TIP WAS OUT OF THE DEVICE. THE NEEDLE ITSELF COULD THEN ONLY BE PUSHED OUT WITH THE GREAT RESISTANCE, AND THE SHEATH WAS PERFORATED. A SECOND NEEDLE WAS THEN INSERTED WITHOUT DIFFICULTY, AND THE INTERVENTION WAS SUCCESSFULLY. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS, ETC.) (IF LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G., 2R, 2L, 4R, AO, AR, 11RI, 11S, ETC.) FROM THE STOMACH TO THE LEFT INTRAHEPATIC BILE DUCT. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. FROM THE STOMACH TO THE DHC, APPROX. 5 CM. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO. YES. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? YES. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. NO. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? N/A, YES, NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO. NO. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO. NO. 10. WHEN WAS THE ISSUE NOTED? E.G., ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919933 ↗
• MalfunctionAug 11, 2025Fracture; Fracture

  THE CASE WAS DETERMINED TO BE REPORTABLE ON 18 JUL 2025 BASED ON THE FOLLOWING ENGINEERING INPUT AFTER THE LAB EVALUATION: "IF A DISTAL KINK OR BREAK HAD BEEN PRESENT, THE ISSUE COULD HAVE BEEN ATTRIBUTED TO USE ERROR. HOWEVER, SINCE ONLY A PROXIMAL BREAK IS EVIDENT, THIS COMPLAINT WILL BE ASSESSED AS A PROXIMAL NEEDLE BREAK. USER WAS CONDUCTING EUS PANCREAS, PUNCTURE PANCREAS BODY FOR FIRST ATTEMPT, THEN SLOWLY RETRACTED THE NEEDLE BUT FOUND OUT NO CELL OBTAINED. USER RETRACTED THE NEEDLE FROM ENDOSCOPE WORKING CHANNEL, THEN RE-INSTALLED THE NEEDLE ONTO ENDOSCOPE WHILE ENCOUNTERED RESISTANCE DURING INSERTING INTO ENDOSCOPE. USER FOUND OUT THE NEEDLE KINK AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. CAN THE FOLLOWING BE CONFIRMED WITH THE CUSTOMER? COULD YOU PLEASE CLARIFY WHETHER THE NEEDLE WAS KINKED AT THE PROXIMAL END, THE DISTAL END, OR BOTH? THE IMAGES SUGGEST THAT KINKS MAY BE PRESENT AT BOTH LOCATIONS. PROXIMAL E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769653 ↗
• 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 ↗
• InjuryApr 22, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  DURING LYMPH NODE PUNCTURE, THE NEEDLE BENT AND BROKE. THE BROKEN PART REMAINED STUCK IN THE PATIENT'S BRONCHIAL WALL BEFORE BEING REMOVED BY THE PRACTITIONER USING A SINGLE-USE ENDOSCOPE. TO COMPLETE THE PROCEDURE, ANOTHER NEEDLE OF THE SAME REFERENCE AND BATCH NUMBER WAS USED SUCCESSFULLY. AS PER EMAIL FROM SALES REP: 1. WILL THE COMPLAINT DEVICE BE RETURNED? CURRENTLY, TRACKWISE INDICATES ¿UNSURE.¿ : WE CONFIRM THE ABSENCE OF THE MEDICAL DEVICE FOR EXPERTISE 2. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE: THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS. 3. IF THE REPORT INVOLVES A KINK, BEND, OR BREAK IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END : WE DON¿T KNOW. 4. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO : WE DON'T KNOW BECAUSE SEVERAL LYMPH NODES TREATED, INCLUDING 1 DIFFICULT BUT THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS. 5. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? WE DON'T KNOW BECAUSE SEVERAL LYMPH NODES TREATED, INCLUDING 1 DIFFICULT BUT THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS 6. WHAT IS THE SCOPE MA

  Patient problems: Foreign Body In Patient

  MAUDE report 21883877 ↗
• 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 ↗
• MalfunctionFeb 14, 2020Material Twisted/Bent; Material Twisted/Bent

  WHEN PACKAGE WAS OPEN, STYLET WAS ALREADY OUT OF PLACE. WENT AHEAD TO CHECK, THE FNA SHIFT WAS BENT (THE POINT CONNECTING FNA SHIFT AND HANDLE). UNABLE TO PUSH STYLET IN AS WELL. STYLET KINKED WHEN IT WAS RE-INSERTED AFTER PULLING OUT. DEVICE WAS RETURNED AND EVALUATED ON 16-JAN-2020 AND A KINK WAS NOTED BELOW THE SHEATH EXTENDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710579 ↗
• MalfunctionFeb 14, 2020Fracture; Fracture

  COMPLETED CUSTOMER REPORTING FORM AND ADDITIONAL INFORMATION WAS RECEIVED ON 17-JAN-2020 INDICATING NEEDLE BREAKAGE. THE COMPLAINT DEVICE WAS EVALUATED ON (B)(6) 2020 AND THE NEEDLE WAS CONFIRMED TO BE BROKEN BELOW THE SHEATH EXTENDER. DURING DECOMPRESSION OF THE CYST, THE NEEDLE BROKE AFTER PASSING THROUGH THE CANAL AND TRYING TO OPEN THE NEEDLE IN THE STOMACH. THE NEEDLE WAS NO LONGER HIDDEN IN THE COVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710412 ↗
• MalfunctionJan 24, 2020Break; Fracture; No Apparent Adverse Event; Break; Fracture; No Apparent Adverse Event

  DURING ECHO ENDOSCOPY WITH BIOPSY, WHEN STAFF WANTED TO MAKE A PONCTION, DIFFICULTY TO GET THE NEEDLE OUT OF THE ECHOENDO. NEEDLE BROKE OFF INTO ECHOENDOSCOPE. WHEN NEEDLE WAS RETRIEVED STAFF NOTICED A LACK OF BEVELLED EDGE. CONSEQUENCES: LONGER ANESTHESIA. USE OF NEW NEEDLE. EXTRA FINANCIAL COST.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9625563 ↗
• MalfunctionJan 16, 2020Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T FUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE.SO THEY USED ANOTHER ECHO-19. IT WAS INDICATED THAT THE DISTAL END OF THE NEEDLE WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596216 ↗
• 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 19, 2019Material Twisted/Bent; Material Twisted/Bent

  DISTAL TIP OF NEEDLE DEFORMED OBSERVED DURING THE LAB EVALUATION OF (B)(4). RELATED TO MDR REF#: 3001845648-2019-00594.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9494096 ↗
• 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 ↗
• MalfunctionDec 10, 2019Material Twisted/Bent; Material Twisted/Bent

  NEEDLE TIP WAS BEND. RESULT OF THIS DEFECT APPLIANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443156 ↗

Other Cook Ireland Ltd products

• Evolution21 models · 458 reports
• Zilver PTX28 models · 302 reports · 2 recalls
• Zilver 63555 models · 296 reports
• Zimmon43 models · 274 reports
• EchoTip ProCore8 models · 263 reports
• Zilver Vena19 models · 108 reports
• Resonance4 models · 97 reports
• Zilver 51820 models · 83 reports