EchoTip ProCore G55738Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002557383), received between Apr 19, 2016 and May 14, 2020 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Kinked” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 31, 2019Break; Break

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: THE PATIENT UNDERWENT AN FNB OF A RECTAL MASS IN WHICH THE ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE, G55738, WAS USED. THE NEEDLE BROKE OFF INSIDE OF THE PATIENT BUT THE PHYSICIAN WAS ABLE TO RETRIEVE WITH THE FORCEPS. A PROCORE 22 NEEDLE WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THE PHYSICIAN CONFIRMED THE LESION WAS VERY TOUGH AND SCARRED. THERE WAS NO HARM TOT HE PATIENT AND NO ADDITIONAL PROCEDURES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8657525 ↗
• MalfunctionMay 31, 2018Kinked; Kinked

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. AS REPORTED TO CUSTOMER RELATIONS, "AFTER PLACING FNB NEEDLE DOWN SCOPE HAVING INCREASED DIFFICULTY EXTENDING NEEDLE INTO MASS WHICH DID NOT OCCUR WITH PREVIOUS FNA NEEDLE, ABLE TO EXTEND INTO THE MASS LOCATED AT HEAD OF PANCREAS AT THAT POINT THEN HAD INCREASED DIFFICULTY REMOVING STYLET THROUGHOUT THE WHOLE LENGTH OF STYLET- UNABLE TO REPLACE STYLET INTO NEEDLE TO PROCESS SPECIMEN, THEN WHEN ATTEMPTING TO PLACE NEEDLE BACK IN SCOPE UNABLE TO TURN ONTO BIOPSY CHANNEL TO LOCK, NEEDLE REMOVED AND ANOTHER PRO CORE FNB NEEDLE SAME CALIBER AND STYLE USED WITHOUT DIFFICULTY." DURING THE DEVICE EVALUATION IT WAS NOTED THAT THE NEEDLE WAS CRUMPLED IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7556873 ↗
• MalfunctionMar 30, 2018Kinked; Material Deformation; Kinked; Material Deformation

  THE NEEDLE BENT DURING A PUNCTION UNDER HIGH ENDO ENDOSCOPY. RISK OF PERFORATIONS. CHANGE OF NEEDLE. "AS PER COMPLAINT FORM": AFTER THE 1ST PASSAGE THE NEEDLE WAS BADLY BENT. DOCTOR CHANGED FOR ANOTHER NEEDLE FOR THE REST OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385111 ↗
• MalfunctionFeb 28, 2018Bent; Kinked; Bent; Kinked

  ECHOTIP ULTRA 25 GA NEEDLE BENT AFTER EXTENDING FROM SHEATH. PRODUCT AVAILABLE FOR RETURN AND INSPECTION. LOT NUMBER C1404483.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303221 ↗
• MalfunctionFeb 28, 2018Bent; Kinked; Bent; Kinked

  A 25G COOK PROCORE NEEDLE WAS USED TO PUNCTURE THE PAPILLA WITH THE SCOPE IN D2. THE NEEDLE COULD NOT COME OUT OF THE SCOPE EASILY AND THERE WAS DIFFICULTY IN PERFORMING THE FNA. POST PUNCTURE THE NEEDLE COULD NOT BE PUSHED FROM THE SHEATH TO EXPRESS THE TISSUE ONTO THE SLIDE. A NEW 25G COOK ULTRA NEEDLE WAS USED IN PLACE WITH NO FURTHER DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302838 ↗
• MalfunctionFeb 21, 2018Bent; Kinked; Bent; Kinked

  AS PER CC FORM: FIRST NEEDLE: THEY OPENED THE PACKAGE AND CHECKED THE NEEDLE, THEY INTRODUCED THE NEEDLE THROUGHOUT THE OPERATING CHANNEL WITHOUT PROBLEM AND THEY STARTED A PUNCTURE WITH THE NEEDLE 25 PROCORE. THEY DID A PASSAGE IN THE LESION. THEY PUT MATERIAL INTO THE POT AND FLUSHED THE NEEDLE AND WHEN THEY TRIED TO REPOSITION THE MANDRIL IN THE SHEATH, IT WAS DIFFICULT TO RE-INTRODUCE IT FOR DOING A SECOND PASSAGE IN THE LESION. THE INCIDENT HAPPENED DURING THE SECOND PUNCTURE, THEY COULD NOT PULL ON THE MANDRIL DURING SAMPLING, THERE WAS A BIG RESISTANCE TO PULL IT OUT. WHEN PULLING ON THE DISTAL END OF THE MADRIL, THE TIP BROKE (KNOB). THE SAMPLING WAS STOPPED AND THE BIOPSY NEEDLE WAS RETRIEVED. SECOND NEEDLE: THEY OPENED THE PACKAGE AND CHECKED THE NEEDLE, THEY INTRODUCED THE NEEDLE THROUGHOUT THE OPERATING CHANNEL WITHOUT PROBLEM AND THEY STARTED A PUNCTURE WITH THE NEEDLE 25 PROCORE. THEY DID A PASSAGE IN THE LESION. THEY PUT MATERIAL INTO THE POT AND FLUSHED THE NEEDLE AND WHEN THEY TRIED TO REPOSITION THE MANDRIL IN THE SHEATH, IT GOT BLOCKED MAKING IT IMPOSSIBLE TO RE-INTRODUCE IT FOR A SECOND PASSAGE IN THE LESION. STYLET STAYED BLOCKED IN THE NEEDLE AND WAS IMPOSSIBL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285831 ↗
• MalfunctionJan 11, 2018Kinked; Kinked

  THIS FOLLOW UP REPORT IS BEING SUBMITTED BASED ON THE CONCLUSION OF THE INVESTIGATION. THEY STARTED A PUNCTION WITH THE NEEDLE 25 PROCORE, THEY DID A PASSAGE IN THE LESION AND WHEN THEY TRIED TO REPOSITION THE MANDRILL IN THE SHEATH, IT GOT BLOCKED AT THE LEVEL OF THE JUNCTION NEEDLE / SHEATH. IMPOSSIBLE TO REINTRODUCE IT TO DO A SECOND PASSAGE IN THE LESION. "AS PER COMPLAINT FORM": THEY OPENED THE PACKAGE AND CHECKED THE NEEDLE ALL WAS GOOD. THEY INTRODUCED THE NEEDLE THOUGHT THE OPERATING CHANNEL WITHOUT PROBLEM AND THEY STARTED A PUNCTION WITH THE NEEDLE 25 PROCORE, THEY DID A PASSAGE IN THE LESION. THEY PUT MATERIAL INTO THE POT AND FLUSHED THE NEEDLE AND WHEN THEY TRIED TO REPOSITION THE MANDRIL IN THE SHEATH, IT GOT BLOCKED AT THE LEVEL OF THE JUNCTION NEEDLE / SHEATH. IMPOSSIBLE TO REINTRODUCE IT FOR DOING A SECOND PASSAGE IN THE LESION . THY SHOULD TAKE ANOTHER PUNCTION NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7182299 ↗
• MalfunctionDec 29, 2017Bent; Kinked; Bent; Kinked

  THIS FOLLOW UP IS REQUIRED DUE TO THE CONCLUSION OF THE INVESTIGATION. THEY WERE FLUSHING OUT THE TISSUE WITH SALINE AND THE WHOLE NEEDLE STARTED TO BEND. SOMETHING WAS CLOGGED CAUSING THE WATER TO BEND THE NEEDLE. THEY OPENED A NEW NEEDLE AND WORKED SUCCESSFULLY TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153777 ↗
• MalfunctionDec 13, 2017Kinked; Kinked

  THE FIRST BIOPSY WAS PERFORMED WITH A PROCORE 22G DEVICE WITH A DOOR-KNOCKING METHOD. HOWEVER BECAUSE NO SPECIMEN WAS COLLECTED DESPITE TWO ATTEMPTS, IT WAS REPLACED WITH A PROCORE 25G DEVICE (= COMPLAINT DEVICE). SIZE OF THE TUMOR WAS 30-40 MM. SHEATH ADJUSTER WAS MOVED ABOUT 2 CM AND NEEDLE LENGTH WAS SET ABOUT 3 CM. DURING BIOPSY WITH THE 25G DEVICE (TWO TIMES), THE PHYSICIAN FELT SOMETHING WRONG DURING THE DOOR-KNOCKING METHOD AS IF THE HANDLE WAS PUSHED BACK BY A SPRING JUST BEFORE HITTING THE NEEDLE STOPPER. THE NEEDLE COULD ADVANCE INTO THE TUMOUR DESPITE THE ABNORMALITY, BUT THE STYLET COULD NOT BE FULLY REMOVED. (ONLY APPROXIMATELY 10 CM COULD BE REMOVED.) THEREFORE, THE WHOLE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND REPLACED WITH A NEW PROCORE 22G DEVICE. THE REPLACEMENT 22G DEVICE COULD PUNCTURE THE TARGET SITE AND COLLECT THE SPECIMEN, THEN THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE DEVICE WAS EVALUATED ON THE 17 NOV 2017 AND THE NEEDLE WAS CONFIRMED TO BE CRUMPLED IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7112986 ↗
• MalfunctionNov 27, 2017Retraction Problem; Retraction Problem

  THE NEEDLE WAS UNABLE TO MOVE UP/DOWN. AS REPORTED BY THE CUSTOMER: "WHEN YOU UNLOCK THE DIAL, YOU PHYSICALLY COULD NOT MOVE IT UP AND DOWN." ADDITIONAL INFORMATION WAS RECEIVED ON 08-NOV-2017 CONFIRMING: "I CHECKED WITH THE NURSE THAT WAS DOING PROCEDURES THAT DAY. SHE SAID ONE OF THE NEEDLES WAS ABLE TO ADVANCE BUT THE DOCTOR WAS UNABLE TO RETRACT IT. THEY HAD TO PULL IT OUT OF THE SCOPE WITH THE NEEDLE STILL OUT. THE OTHER NEEDLE WAS UNABLE TO ADVANCE AT ALL" THIS REPORT RELATES TO THE NEEDLE THAT WAS UNABLE TO BE RETRACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7059338 ↗
• MalfunctionNov 27, 2017Bent; Kinked; Bent; Kinked

  THE TIP OF THE NEEDLE WAS BENT OUT OF THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7059320 ↗
• MalfunctionNov 9, 2017Bent; Kinked; Bent; Kinked

  PHYSICIAN DID EUS-FNB IN PANCREAS HEAD PUNCTURE BUT THE NEEDLE DIDN'T PUNCTURE AT ALL. HE USED ANOTHER ECHO-HD-25-C AND PROCEDURE DID SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7014008 ↗
• MalfunctionSep 28, 2017Kinked; Kinked

  THE DEVICE WAS USED FOR (B)(4). THOUGH THE PHYSICIAN ATTEMPTED TO PUNCTURE THE PANCREAS HEAD THROUGH THE DESCENDING PART OF THE DUODENUM, THE NEEDLE DID NOT ADVANCE. THEN, OLYMPUS'S EZ SHOT 2 WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900349 ↗
• MalfunctionSep 22, 2017Kinked; Kinked

  THE USER PUNCTURED WITH DEVICE AT SECOND TIME. THEN THE NEEDLE COULD NOT ADVANCE FROM THE SHEATH. REPLACE NEW DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886163 ↗
• MalfunctionJul 20, 2017Wrinkled; Wrinkled

  THE USER PUNCTURED THE PANCREAS HEAD USING ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE THROUGH THE DESCENDING PART OF THE DUODENUM. RESISTANCE WAS MET BUT HE STROKED SEVERAL TIMES. THEN HE DETACHED THE DEVICE FROM THE ENDOSCOPE AND ATTEMPTED TO INSERT THE STYLET TO COLLECT THE SPECIMENS. HOWEVER THE STYLET WOULD NOT ADVANCE ANY FURTHER THAN THE MIDDLE OF THE DEVICE. HE REPLACED IT WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED "ON" THE 23 JUN 2017 AND THE NEEDLE WAS CONFIRMED TO BE CRUMPLED IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727900 ↗
• MalfunctionFeb 23, 2017Kinked; Kinked

  AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN USED A 25G CORE NEEDLE IN SUSPICIOUS HEAD OF PANCREAS MASS. UPON INITIAL INSERTION OF NEEDLE INTO MASS, NURSE NOTED STYLET POPPED OUT OF NEEDLE APPROXIMATELY ONE TO TWO INCHES. WHILE PHYSICIAN WAS MOVING NEEDLE IN AND OUT, NURSE WAS ATTEMPTING TO RETRIEVE THE STYLET IN A SLOW PULL MANNER. SHE OBSERVED EXTREME DIFFICULTY REMOVING THE STYLET AND EVENTUALLY NOTICED A COILING OR CURLING OF THE STYLET. UPON FINAL REMOVAL OF THE STYLET, IT WAS NOTED IT WOULD BE IMPOSSIBLE TO REINSERT INTO THE NEEDLE. THE STYLET WAS COMPLETELY DEFORMED. EVENTUALLY WHEN SHE ATTEMPTED TO COIL IT TO RETURN TO MANUFACTURER, IT BROKE." DEVICE RETURNED AND THE NEEDLE WAS CONFIRMED TO BE CRUMPLED IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6352632 ↗
• MalfunctionApr 19, 2016Break; Retraction Problem; Break; Retraction Problem

  WHILE ATTEMPTING TO COLLECT A SAMPLE WITH THIS DEVICE, THE NEEDLE WAS ADVANCED INTO THE MASS AND THE HANDLE BROKE, THEREFORE THE NEEDLE WAS UNABLE TO RETRACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5586395 ↗