EchoTip ProCoreRecalls & reported problems across all models
Cook Ireland Ltd · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 263
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls
- 0
We found 8 models of EchoTip ProCore by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 263 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Mar 19, 2026 — classified as 78 injuries, 185 malfunctions.
The most frequently reported specific device problem is “Break” (140 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. 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
Reports received per month, all models
Most reported EchoTip ProCore problems
Device problems
- Break140
- Kinked40
- Retraction Problem40
- Bent36
- Fracture12
- Material Deformation12
- Material Twisted/Bent8
- Material Perforation7
Patient problems
- No Known Impact Or Consequence To Patient142
- No Consequences Or Impact To Patient62
- Foreign Body In Patient60
- No Clinical Signs, Symptoms or Conditions6
- Device Embedded In Tissue or Plaque3
- Abdominal Pain1
- Abscess1
- Hemorrhage/Blood Loss/Bleeding1
EchoTip ProCore models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EchoTip ProCore G34785Biopsy needle97 reports
- EchoTip ProCore G34279Biopsy needle63 reports
- EchoTip ProCore G34281Biopsy needle28 reports
- EchoTip ProCore G53585Biopsy needle26 reports
- EchoTip ProCore G55738Biopsy needle18 reports
- EchoTip ProCore G55736Biopsy needle17 reports
- EchoTip ProCore G34280Biopsy needle7 reports
- EchoTip ProCore G34282Biopsy needle7 reports
Recent EchoTip ProCore adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026
ENDOBRONCHIAL ULTRASOUND NEEDLE USED FOR NEEDLE BIOPSY DURING BRONCH PROCEDURE; NEEDLE BROKE OFF IN THE PATIENTS BRONCHIAL. DR. (B)(6) TO USE BIOPSY FORCEPS TO RETRIEVE BROKEN NEEDLE PIECE OUT OF BRONCHIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638360 ↗MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
A COMPLETE INITIAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 21 NOV 2025. THE NEEDLE DID NOT ABLE TO ADVANCE OUT FROM THE SHEATH. EBUS PRO PTB FOR HEPATITIS B 1. CAN IT BE CLARIFIED WHAT IS MEAN BY EBUS PRO PTB PROCEDURE? ANS. EBUS TBNA. 2. 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.) ANS. LUNG, NODE 7. 3. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? ANS. YES, NEEDLE COULDN'T PUNCTURE, DR TRIED AROUND 6-7 TIMES. PREVIOUSLY HAS NO PROBLEM WITH OUR NEEDLE, NOW HE'S WORRIED TO JUST SIMPLY USE OUR NEEDLE, WORRYING THE SAME THING WOULD HAPPEN AGAIN. 4. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? ANS. OLYMPUS, BF-TH1100, BF-UC180F. 5. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? ANS. MAINTAINED AS USUAL. 6. WAS THE DEVICE USED IN A TORTUOUS POSITION? ANS. NO. 7. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? N/A, YES, NO. ANS. NO. 8. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO. ANS. NO. 9. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO. ANS. NO. 10. WHEN WAS THE ISSUE NOTED?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724189 ↗MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent
AFTER A SECOND PUNCTURE, THE NEEDLE BECAME TWISTED IN THE LYMPH NODE, MAKING IT IMPOSSIBLE TO WITHDRAW IT COMPLETELY INTO ITS SHEATH. POSSIBLE DAMAGE TO THE INNER SHEATH OF THE BRONCHIAL ECHOENDOSCOPE. NEEDLE CHANGED IN ORDER TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485435 ↗InjuryOct 29, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-DEC-2025.
Patient problems: Foreign Body In Patient
MAUDE report 23413095 ↗MalfunctionOct 16, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
FNB PROCEDURE WAS BEING PERFORMED WITH ECHO-HD-3-20-C. 1ST PUNCTURE WAS SUCCESSFUL. BUT AT THE 2ND PUNCTURE, THE ASSISTANT NURSE FOUND THAT THE NEEDLE TIP BENT. SHE WAS WORRIED ABOUT THE NEEDLE BROKEN. SO THE PHYSICIAN WITHDREW THE NEEDLE OUT OF THE SCOPE AND SESSION REPEATED WITH ANOTHER NEW NEEDLE.WITH 2ND NEEDLE, 3RD SESSION FINISHED SUCCESSFULLY. BUT AT THE BEGINNING OF 4TH SESSION, THE PHYSICIAN FOUND THAT THE NEEDLE TIP BENT. SO HE CHANGE NEW NEEDLE AGAIN. THIS CASE FINISHED AT 5TH SESSIONS WITH 3 PROCORE NEEDLES. ADDITIONAL INFORMATION RECEIVED ON 25SEP2025. 1. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? NO. 2. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS, UCT-260. 3. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? NO. 4. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. 5. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO. 6. WHEN WAS THE ISSUE NOTED? E.G., ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? 7. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TORE TURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) NO 8. IF THE REPORT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309647 ↗InjurySep 25, 2025Break; Fracture; Break; Fracture
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-NOV-2025.
Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding
MAUDE report 23151815 ↗InjurySep 22, 2025Break; Fracture; Break; Fracture
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28-OCT-2025.
Patient problems: Foreign Body In Patient
MAUDE report 23118972 ↗MalfunctionSep 22, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
FNB PROCEDURE WAS BEING PERFORMED WITH ECHO-HD-3-20-C. 3RD PUNCTURE WAS SUCCESSFUL. BUT AT THE 4TH PUNCTURE, THE ASSISTANT NURSE FOUND THAT THE NEEDLE TIP BENT. SHE WAS WORRIED ABOUT THE NEEDLE BROKEN. SO, THE PHYSICIAN WITHDREW THE NEEDLE OUT OF THE SCOPE AND SESSION REPEATED WITH ANOTHER NEW NEEDLE. (REPLACED ANOTHER PROCORE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23110221 ↗MalfunctionSep 16, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
AS REPORTED ON AHS MDIP REPORT: "PATIENT WAS HAVING AN EBUS PROCEDURE DONE. WHEN REMOVING THE SAMPLE FROM THE NEEDLE I WAS UNABLE TO PULL THE NEEDLE BACK INTO THE SHEATH. PHYSICIAN MADE AWARE. NEW NEEDLE OPENED TO FINISH THE PROCEDURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069916 ↗InjuryAug 22, 2025Fracture; Fracture
FNB PROCEDURE WAS BEING PERFORMED WITH ECHO-HD-3-20-C. 4 SESSIONS WERE FINISHED. HOWEVER, AT THE 4TH TIME OF FINISHING, THE ASSISTANT NURSE RECOGNIZED THAT THE TIP OF THE NEEDLE WAS BROKEN. THE PHYSICIAN EXAMINED BY CT AND X-RAY, HE FOUND THAT THE NEEDLE TIP WAS BROKEN AND REMAINED IN THE PANCREATIC MASS. FURTHER ENDOSCOPIC PROCEDURE WILL BE PERFORMED WITHIN THIS WEEK.
Patient problems: Foreign Body In Patient
MAUDE report 22873203 ↗MalfunctionMay 14, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
COMPLAINT CALLED IN BY DM ON (B)(6) 2020--DID 15JAN2020. AS REPORTED TO CUSTOMER RELATIONS: "TRYING TO BIOPSY HEAD OF THE PANCREAS, AND THEY COULD NOT ACTUATE THE HANDLE (NEEDLE WOULD NOT COME OUT). ANOTHER OF THE SAME GPN WAS USED TO COMPLETE PROCEDURE." ADDITIONAL INFORMATION PROVIDED BY DM ON 16APR2020: "FROM EVALUATION THE RETURNED COMPLAINT DEVICE IT SEEMS AN ATTEMPT WAS MADE AT A PUNCTURE DUE TO THE NEEDLE DAMAGE OBSERVED AT THE NEEDLE TIP . IF A PUNCTURE WAS ATTEMPTED, WAS THE STYLET IN PLACE? OR WAS IT REMOVED PRIOR TO ADVANCING INTO THE TARGET SITE? THEY USE THIS NEEDLE FAIRLY OFTEN WITHOUT PROBLEMS. THEY DO NOT REMOVE THE STYLET PRIOR TO PUNCTURE BUT MAY PULL IT BACK FROM THE TIP AT TIMES. ITS HARD TO KNOW AND WILL BE IMPOSSIBLE TO BE CERTAIN ABOUT THIS ON THAT PARTICULAR PROCEDURE SINCE WAS LONG TIME AGO AND THEY DO NOT NOTE WHETHER THEY PULLED BACK THE STYLET ON PUNCTURE. SORRY, NOT MUCH HELP"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10058999 ↗MalfunctionMar 6, 2020Fracture; Fracture
IMPOSSIBLE TO INSERT THE MANDREL INTO THE NEEDLE AFTER A FIRST PUNCTURE. NEED TO USE A SECOND NEEDLE DEVICE WAS RETURNED AND EVALUATED ON 07-FEB-2020 AND PROXIMAL NEEDLE BREAKAGE WAS CONFIRMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9799381 ↗MalfunctionJan 8, 2020Break; Material Perforation; Break; Material Perforation
NEEDLE WENT TROUGH THE DISTAL PART SHEATH. AS PER CC FORM: WHEN THE NEEDLE WAS PUSHED FORWARD, THE CATHETER WAS PIERCED. THAT WAS NOT ANGLED AT THE TIME. THE ENDOSCOPE AND THE PATIENT REMAINED UNHARMED. THE COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2020 AND THE DISTAL END OF THE NEEDLE WAS CONFIRMED TO BE BROKEN. NO PART OF THE NEEDLE REMAINS IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM IF THE NEEDLE BROKE INSIDE / OUTSIDE THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9563196 ↗MalfunctionDec 24, 2019Break; Break
PRIOR TO PATIENT CONTACT, THE USER FOUND A NEEDLE OR SHEATH BEND OF ECHO-HD-3-20-C/LOT C1637646. ANOTHER ECHO-HD-3-20-C WAS USED INSTEAD. 02DEC2019, (B)(6). AFTER THE FIRST BIOPSY, THE USER REMOVED THE DEVICE FROM THE BODY. WHEN THE USER INSERTED THE STYLET FROM THE HUB, HE FELT RESISTANCE. HE CONTINUED TO INSERTING THE STYLET AND THE NEEDLE CAME OUT FROM THE SHEATH TIP EVEN THOUGH THE HANDLE WAS LOCKED. THEREFORE ANOTHER ECHO-HD-3-20-C INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9516342 ↗MalfunctionDec 12, 2019Retraction Problem; Retraction Problem
THE NEEDLE KINKED UPON FIRST PUNCTURE OF THE LESION. THE NEEDLE WAS RETRACTED BACK INTO THE SHEATH, THE DOCTOR ATTEMPTED A SECOND PUNCTURE BUT FAILED BECAUSE THE NEEDLE WAS UNABLE TO COME OUT FROM THE SHEATH. ADDITIONAL INFORMATION CONFIRMED THAT THE NEEDLE WAS FULLY RETRACTED WITH FORCE PRIOR TO REMOVAL FROM PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9456806 ↗
Other Cook Ireland Ltd products
All Cook Ireland Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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