EchoTip ProCore G34785Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00827002347854), received between Jun 7, 2016 and Oct 16, 2025 — classified as 35 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (68 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 97 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 11, 2019Break; Fracture; Break; Fracture

  DURING AN ENDO SOUND WITH THE PUNCTURE NEEDLE, THE NEEDLE SUDDENLY CAME OFF THE HANDLE AND STUCK IN THE DEVICE. AS PER COMPLAINT FORM: "WHEN THE NEEDLE WAS RETRACTED, THE NEEDLE DETACHED FROM THE HANDLE AND COULD NOT BE PULLED BACK INTO THE TUBE VIA THE HANDLE.". NEEDLE IS COMPLETELY TORN OFF THE HANDLE. PUNCTURE PANCREATIC HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449456 ↗
• MalfunctionDec 9, 2019Break; Break

  DR. (B)(6) GOT SOME SAMPLE IN THE FIRST , SECOND PENETRATION BUT ON THE THIRD 3CM OF NEEDLE WAS BROKEN. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DISTAL NEEDLE BREAKAGE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9436783 ↗
• MalfunctionDec 2, 2019Retraction Problem; Retraction Problem

  PATIENT WAS HAVING AN EUS PROCEDURE TO SAMPLE A PANCREATIC MASS. THE NEEDLE WAS USED AS PER THE IFU. AFTER THE FOURTH PASS THE DEVICE WAS REMOVED FROM THE SCOPE AND THE NEEDLE EXTENDED FROM THE SHEATH TO COLLECT THE SAMPLE. THE SAMPLE WAS COLLECTED. THE NURSE ATTEMPTED TO RESHEATH THE NEEDLE AND IT WOULD NOT RETRACT. AS THE PROCEDURE WAS ALREADY FINISHED AT THIS POINT THE DEVICE WAS DISPOSED OF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9394579 ↗
• MalfunctionNov 20, 2019Break; Fracture; Break; Fracture

  DR.(B)(6) GOT SOME SAMPLE IN THE FIRST, SECOND PENETRATION BUT ON THE THIRD 1.5CM OF NEEDLE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346433 ↗
• InjuryNov 18, 2019Break; Break

  DURING FNB OPERATION , THE NEEDLES BROKE. IN DETAIL, WHEN DR. (B)(6) WAS PUNCTURING THE HEAD OF PANCREAS FROME DUODENUM, 1.5 CM OF NEEDLE WAS BROKEN AND THEN THE NEEDLES TIP WAS EMBEDDED IN THE DUODENUM.

  Patient problems: Foreign Body In Patient

  MAUDE report 9334929 ↗
• MalfunctionOct 31, 2019Break; Break

  THE USER ADVANCED ECHO-HD-3-20-C/LOT C1617971 INTO OLYMPUS'S UCT260. BIOPSY OF STOMACH SMT WAS PERFORMED THREE TIMES. ON THE FIRST AND THE SECOND BIOPSY, 60 SCROLLS (= 30 TIMES OF NEEDLE ADVANCEMENT PER BIOPSY) WERE MADE . THEN, THE THIRD BIOPSY WAS PERFORMED BUT THE NEEDLE BECAME UNABLE TO MOVE BY HANDLE MANIPULATION AND THE NEEDLE TIP COULD NOT BE RETRACTED INSIDE THE SHEATH DURING THE THIRD BIOPSY. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE(BOSTON'S ACQUIRE) AND COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260359 ↗
• InjuryOct 29, 2019Break; Break

  AT THE SECOND PUNCTION, THE NEEDLE'S TIP BROKE AND STAYED INSIDE THE PATIENT AS PER COMPLAINT FORM: "DURING THE PUNCTURE UNDER ULTRASOUND ENDOSCOPY, DURING THE SECOND PASS THE NEEDLE BROKE AND BECAME TRAPPED IN THE PUNCTURE MASS, THE PANCREAS. A PIECE OF THE NEEDLE TIP REMAINED IN THE PATIENT. AFTER SCANNING, THE PATIENT ATE AND WENT HOME."

  Patient problems: Foreign Body In Patient

  MAUDE report 9252241 ↗
• InjurySep 3, 2019Break; Break

  DURING AN ENDOSCOPIC PUNCTION, PERFORMED BY DR. CHAOUCHI, THE NEEDLE OF THE ECHO TIP BROKE AND REMAINED IN THE PATIENT'S MUCOSA. THE PIECE OF NEEDLE WAS RETRIEVED AND THE EVENT HAD NO CONSEQUENCE FOR THE PATIENT IN IMMEDIATE POST-OP. THE DEVICE IS QUARANTINED AT THE PHARMACY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8955970 ↗
• InjurySep 3, 2019Break; Break

  NEEDLE TIP BROKEN INTO THE PATIENT, PATIENT IS TODAY GOING WELL BUT AFTER EXAMINATION HE DID AN ABSCESS. THEY PERFORMED A SCANNER FOR CONFIRMATION AND THEY COULD SEE NEEDLE TIP AROUND 1 CM INTO THE LESION . LESION WAS IN THE PANCREAS TAIL, VERY HARD LESION. DR MADE 2 PASS AND THE NEEDLE BROKE AT THE SECOND. AS PER COMPLETED CUSTOMER COMPLAINT FORM: CUSTOMER OPENED THE SEALED PACKAGE WITHOUT PROBLEM. THEY CHECKED THE DEVICE BEFORE TO USE, ALL SEEMED OK. THEY PERFORMED EUS EXAMINATION AND DECIDED TO DO PUNCTION. LESION WAS IN PANCREAS TAIL, AND ENCHO ENDOSCOPE WAS NOT TOO MUCH BENDING. THEY PERFORMED THE FIRST PUNCTION BUT LESION WAS VERY VERY HARD LIKE A STONE LESION, THEY GET SAMPLE AND DECIDED TO DO SECOND PUNCTION. TIP OF THE NEEDLE WAS A A LITTLE BEND BUT SEEMED NOT WEAKENED. THEY PERFORMED THE SECOND PUNCTION AND THEY THEY REMOVED THE DEVICE FROM THE SCOPE THEY SAW THAT TIP OF THE NEEDLE WAS MISSING. THEY DID A THIRD PUNCTION WITH ACQUIRE NEEDLE AND STOP EXAMINATION. AT THIS MOMENT THEY DIDN'T KNOW THAT TIP OF THE NEEDLE WAS INSIDE THE PATIENT. SOME DAY LATER PATIENT WAS PAINFUL AND THEY DID A SCANNER (CRT) AND THEY COULD SEE THE TIP OF THE NEEDLE INTO THE LESION. PATIENT IS ST

  Patient problems: Abscess; Foreign Body In Patient

  MAUDE report 8954713 ↗
• InjuryAug 2, 2019Break; Break

  THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. ON THE THIRD PASS WITH THE PROCORE 20 NEEDLE THE PANCREATIC MASS WAS PUNCTURED AND THEN THE STYLET WAS REMOVED. WHEN THE DOCTOR BEGAN TO PULL BACK SLIGHTLY ON THE NEEDLE TO COMMENCE FANNING HE FELT NO RESISTANCE AND NOTED THE NEEDLE WAS NOT MOVING ON THE ULTRASOUND IMAGE (269656). HE IMMEDIATELY REMOVED THE SCOPE FROM THE PATIENT AND WHEN THE SCOPE WAS WITHDRAWN THE SHAFT OF THE NEEDLE WAS STILL PROTRUDING FROM THE PATIENTS MOUTH. A NURSE GRABBED THE NEEDLE SHAFT AND PULLED IT OUT OF THE PATIENT. AS THE END OF THE NEEDLE CAME OUT OF THE PATIENTS MOUTH THE NURSE SUFFERED A NEEDLE STICK INJURY TO THE ARM FROM THE END OF THE NEEDLE (271124). THE PROCEDURE WAS COMPLETED WITH ANOTHER PROCORE 20 NEEDLE. THERE WERE NO REPORTED ADVERSE EVENTS TO THE PATIENT. THE NURSE UNDERWENT NEEDLE STICK INJURY PROTOCOL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8854320 ↗
• MalfunctionAug 2, 2019Break; Break

  THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. AFTER THE SECOND PASS THE NEEDLE WAS REMOVED FROM THE SCOPE AND THE NURSES WERE TRYING TO PLACE THE SECOND SAMPLE INTO A POT. WHEN REINSERTING THE STYLET IT BECAME APPARENT THE NEEDLE HAD BROKEN AS ALTHOUGH THE SAFETY RING WAS LOCKED ON 2CM THE NEEDLE WAS PROTRUDING APPROX. 10CM OUT OF THE END OF THE SHEATH AND CONTINUED TO MOVE OUT AS THE STYLET WAS PUSHED IN. THE DEVICE WAS THEN PUT ASIDE AND ANOTHER PROCORE 20 NEEDLE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854193 ↗
• InjuryAug 2, 2019Break; Break

  THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. ON THE THIRD PASS WITH THE PROCORE 20 NEEDLE THE PANCREATIC MASS WAS PUNCTURED AND THEN THE STYLET WAS REMOVED. WHEN THE DOCTOR BEGAN TO PULL BACK SLIGHTLY ON THE NEEDLE TO COMMENCE FANNING HE FELT NO RESISTANCE AND NOTED THE NEEDLE WAS NOT MOVING ON THE ULTRASOUND IMAGE (269656). HE IMMEDIATELY REMOVED THE SCOPE FROM THE PATIENT AND WHEN THE SCOPE WAS WITHDRAWN THE SHAFT OF THE NEEDLE WAS STILL PROTRUDING FROM THE PATIENTS MOUTH. A NURSE GRABBED THE NEEDLE SHAFT AND PULLED IT OUT OF THE PATIENT. AS THE END OF THE NEEDLE CAME OUT OF THE PATIENTS MOUTH THE NURSE SUFFERED A NEEDLE STICK INJURY TO THE ARM FROM THE END OF THE NEEDLE (271124). THE PROCEDURE WAS COMPLETED WITH ANOTHER PROCORE 20 NEEDLE. THERE WERE NO REPORTED ADVERSE EVENTS TO THE PATIENT. THE NURSE UNDERWENT NEEDLE STICK INJURY PROTOCOL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8854182 ↗
• MalfunctionJul 18, 2019Material Perforation; Material Perforation

  DURING MANIPULATION AT THE ENDOSCOPIES IT WAS FOUND A DISINSERTION OF THE HANDLE AND THE NEEDLE. THE HANDLE SLIDES WHILE THE NEEDLE SEEMS DISINSERTED. THE NON-FUNCTIONAL DEVICE LED TO THE NEED TO USE ANOTHER DEVICE AND CUSTOMER WOULD LIKE A FREE OF CHARGE OF CREDIT NOTE. DEVICE WAS NOT KEPT. INCIDENT DATE TO BE CONFIRMED. AS PER COMPLAINT FORM : "PUNCTURE AT THE HOOK OF THE PANCREAS. DURING THE FIRST PUNCTURE VERY BIG DIFFICULTY IN GETTING OUT THE NEEDLE. IT EMERGED FROM THE OPERATING CHANNEL OF THE ENDOSCOPE. THE NEEDLE HAD TO CROSS THE SHEATH."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802999 ↗
• MalfunctionJul 1, 2019Retraction Problem; Retraction Problem

  THEY TRIED RETRACTING NEEDLE INTO SHEATH BY PULLING BACK ON HANDLE SHAFT ON SAFETY RING 0CM MARK. BUT THE NEEDLE DID NOT RETRACT INTO SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747261 ↗
• InjuryJun 27, 2019Break; Break

  THE DEVICE WAS ADVANCED TO DESIRED POSITION AND USER COMPLETE THE FIRST BIOPSY. BUT THE NEEDLE TIP WAS OFF FROM DEVICE WHILE DOING SECOND ATTEMPT. THE NEEDLE REMAINED IN PATIENT SO FAR.

  Patient problems: Foreign Body In Patient

  MAUDE report 8738746 ↗
• MalfunctionJun 26, 2019Retraction Problem; Retraction Problem

  THE OUTER SHEATH SURFACE CREASED AND THE NEEDLE CANNOT BE ADVANCED AND RETRACTED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735225 ↗
• MalfunctionJun 26, 2019Break; Break

  DR. (B)(6) GOT SOME SAMPLE IN THE FIRST PENETRATION BUT ON THE SECOND ATTEMPT, THE SHEATH BENT. THEY COULD NOT USE THIS PRODUCT ANYMORE FOR BIOPSY, AND THE NEW PROCORE 20G WAS USED. DEVICE WAS RETURNED AND EVALUATED ON 29-MAY-19. PROXIMAL NEEDLE BREAKAGE CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733970 ↗
• MalfunctionJun 10, 2019Break; Break

  WHILE DOING THE PROCEDURE NEEDLE WAS BROKEN IN TO WORKING CHANNEL AND DOCTOR USED ANOTHER NEEDLE AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682758 ↗
• MalfunctionMay 14, 2019Break; Break

  THE EXTREMITY OF THE NEEDLE SEPARATED (AROUND 3 CM), BROKE AND WAS FOUND IN THE SHEATH OF THE ENDOSCOPE. PATIENT WAS NOT INJURED, ANOTHER DEVICE WITH THE SAME LOT NUMBER WAS USE, AND THERE WAS NO ISSUE. AS PER CUSTOMER COMPLAINT FORM: "THE SITE TO BE PUNCTURED WAS VERY COMPLICATED AND REQUIRED A SIGNIFICANT BEND AND RETRO VISION OF THE ECHOENDOSCOPE. THE RECTOR WAS USED FOR THE PUNCTION. THE DOCTOR MANAGED WITH DIFFICULTY TO PUT THE NEEDLE INTO THE TUMOUR AND WHEN THE NURSE TRIED TO REMOVE THE STYLET, THIS ONE COULD ONLY COME OUT OF 3 CM. THE DOCTOR COULD NOT MOVE THE ENDOSCOPE AND THE NURSE HAD TO FORCE HIM TO REMOVE THE STYLET, AND WHEN IT WAS RELEASED THE POSITIONING OF THE ENDOSCOPE HAD CHANGED AND THE DOCTOR DECIDED TO REMOVE THE NEEDLE FROM THE ENDOSCOPE TAKING CARE TO GET THE NEEDLE INTO ITS SHEATH. ON LEAVING THE NEEDLE, THE DOCTOR NOTICED THAT THE TIP OF THE NEEDLE (3 CM) WAS STUCK AT THE ENTRANCE TO THE ECHOENDOSCOPE'S WORKING CHANNEL. THEY DID NOT UNDERSTAND REALLY HOW IT HAPPENED! THE WORKING CHANNEL WAS NOT DAMAGED, FORTUNATELY. THE DOCTOR DECIDED TO MAKE A NEW PUNCTURE WITH A NEW NEEDLE WITH SAME LOT NUMBER AND IT WAS ALSO DIFFICULT BUT THERE WERE 3 PEOPLE TO MAKE THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608013 ↗