EchoTip ProCore G53585Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002535855), received between Jul 5, 2016 and Jul 11, 2019 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2019Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  USER ADVANCED THE DEVICE TO DESIRED POSITION AND FOUND OUT THE NEEDLE CANNOT BE ADVANCED. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. ON COMPLETION OF THE INVESTIGATION, QUALITY ENGINEERING HAVE ASSIGNED THE FOLLOWING FAILURE MODE: USE ERROR SITUATION: PHYSICIAN/ASSISTANT EXTENDS NEEDLE INTO INTENDED BIOPSY SITE WITH THE STYLET PARTIALLY REMOVED." - OVERALL RISK ASSESSED AS MODERATE RISK. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. FDA MDR REPORTING REQUIRED AS THE RISK IS NOT CONSIDERED TO BE 'REMOTE'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780908 ↗
• MalfunctionApr 12, 2019Fracture; Fracture

  PHYSICIAN DID EUS-FNB PROCEDURE. HE FOUND THE TARGER TO PUNCTURE THE MASS. HOWEVER, THE NEEDLE COULDN'T BE PUNCTURED AT ALL. (NEEDLE DIDN'T MOVE AT ALL) HE REMOVED ECHO-HD-22-C OUT OF THE SCOPE. AND USED ANOTHER ECHO-HD-19-C .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8508119 ↗
• MalfunctionMar 15, 2019Retraction Problem; Retraction Problem

  THEY WERE NOT ABLE TO PULL THE NEEDLE FULLY BACK IN THE SHEAT SO THEY HAVE TO REMOVE THE NEEDLE WITH THE SHARP TIP OUTSIDE THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424098 ↗
• MalfunctionMar 15, 2019Break; Break

  THE ECHOENDOSCOPY NEEDLE DID NOT INTERIORIZE INTO THE PROTECTIVE CATHETER WHEN IT WAS MANUALLY RETRACTED. IT WAS NECESSARY TO REMOVE THE DEVICE WITH THE EXPOSED NEEDLE. THERE WAS A RISK OF PERFORATING THE PATIENT AND THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423878 ↗
• MalfunctionMar 7, 2019Retraction Problem; Retraction Problem

  THE COMPLETED CUSTOMER COMPLAINT FORM WAS RECEIVED ON 07-FEB-19 WITH THE COMPLAINT DETAILS. AS PER COMPLAINT FORM "EUS WAS BEING PERFORMED TO DRAIN A CYST IN THE BODY OF THE PANCREAS. IT WAS THE FIRST PASS, IT WAS NOT DIFFICULT TO PASS THE SCOPE OR THE NEEDLE TO THE SITE. THE DR ADVANCED THE NEEDLE INTO THE CYST AND IT WOULD NOT RETRACT BACK INTO THE SHEATH. THE DR REMOVED THE NEEDLE (WITH THE NEEDLE COMING OUT THE FRONT END OF THE SHEATH) VERY CAREFULLY. THE PROCEDURE WAS COMPLETED USING ONE OF THE SAME NEEDLES WITH NO PROBLEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398480 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS DIFFICULT TO REMOVE THE EUS NEEDLE FROM THE METAL HUB ON THE SCOPE AND THEN THE SHEATH BROKE UNDER THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386318 ↗
• MalfunctionFeb 14, 2019Break; Break

  USER CANNOT PULL THE NEEDLE OUT OF SHEATH DURING PROCEDURE AND USER KEEPS ON PULLING THE NEEDLE WHILE THE NEEDLE BROKEN. USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340682 ↗
• MalfunctionJan 15, 2019Material Deformation; Material Deformation

  THIS FOLLOW UP REPORT IS BEING SUBMITTED AS THE INVESTIGATION OF THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION IS COMPLETE. INITIAL REPORT DETAILS: DURING ECOENDOSCOPY, THE NEEDLE DID NOT EXIT THE CATHETER, PREVENTING THE PUNCTURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8247618 ↗
• MalfunctionDec 20, 2018Retraction Problem; Retraction Problem

  DEVICE WAS EVALUATED ON THE 28-NOV-2018: CONFIRMING THE NEEDLE COULD NOT BE RETRACTED INTO THE SHEATH. THIS FILE IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "NON-RETRACTION OF NEEDLE" LARGE GIST TUMOR, BUT FNB NEEDLE BENT AFTER THE FIRST PUNCTURE AND COULD NOT ENTER THE TUMOR ANY MORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184435 ↗
• MalfunctionDec 7, 2018Break; Break

  NEEDLE BROKE OFF. "AS PER COMPLAINT FORM": AFTER THE PUNCTION, THE NEEDLE WAS OUTSIDE OF THE SCOPE, THE NURSE WILL PUT OUT THE NEEDLE TO CHECK THE BIOPSY, THE BROKEN NEEDLE CAME OUT OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8140805 ↗
• InjuryOct 30, 2018Material Deformation; Material Deformation

  AS REPORTED TO CUSTOMER RELATIONS (CR), "THE DOCTOR REPORTS DIFFICULTY IN MANEUVERING THE HANDLE AND WHEN PUNCTURING AND RETRACTING THE NEEDLE IT GOT STUCK, IN BOTH NEEDLES THE SAME HAPPENS. NO PATIENT COMPLICATION. THE DOCTOR DECIDED TO USE ANOTHER NEEDLE OF THE BOSTON BRAND. BOTH NEEDLES WERE USED ONLY AND THEY DID NOT ACHIEVE TISSUE SINCE THEY WERE TUBED. THE NEEDLE IS REVISED AND WE OBSERVE THAT THE NEEDLE OF BOTH DEVICES HAS A BURR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019855 ↗
• MalfunctionOct 24, 2018Break; Break

  NEEDLE BROKE 5 CM AFTER HANDLE DURING PROCEDURE. "AS PER COMPLAINT FORM": DURING THE SECOND PASSAGE THE SHEATH PLUS NEEDLE BROKE APART APPROX. 5 CM AFTER HANDGRIP-END AND REMAINED IN THE WORKING CHANNEL FROM THE ENDOSCOPE. ENDOSCOPE HAD TO BE REMOVED FROM PATIENT TO REMOVE THE DEVICE EXTERNALLY FROM THE WORKING CHANNEL. A FORCEPS WAS USED TO TAKE SHEATH AND NEEDLE OUT OF WORKING CHANNEL. METAL NEEDLE WAS THROWN AWAY, ONLY SHEATH AND HANDLE WILL BE SENT BACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7998902 ↗
• MalfunctionJul 26, 2018Retraction Problem; Retraction Problem

  YIELD WAS TAKEN OUT, AND COULDN'T RETRACT THE NEEDLE INTO THE SHEATH AFTERWARDS THIS HAPPENED WHILE THE NEEDLE WAS OUTSIDE OF THE PATIENT, "AS PER COMPLAINT FORM": WHEN THEY TOOK THE YIELD OUT OF THE NEEDLE ON TO THE GLASS THEY COULDNT RETRACT THE NEEDLE IN THE SHEET ANYMORE. PROCORE BEVEL GOT STUCK ON SHEET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722009 ↗
• MalfunctionApr 30, 2018Kinked; Kinked

  THE DEVICE WAS ADVANCED TO DESIRED POSITION THROUGH ENDOSCOPY BUT FOUND OUT THE TIP OF NEEDLE IS BENT. OPERATOR RETRIEVE THE DEVICE FROM ENDOSCOPY AND FINISHED THE PROCEDURE WITH ANOTHER SAME PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472157 ↗
• MalfunctionApr 9, 2018Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  DEVICE WAS DISCARDED. THE NEEDLE STAY BLOCKED OUTSIDE THE SHEATH, WHILE THE SHEATH GOT OUT OF THE ENDOSCOPE RISK FOR THE STAFF TO GET PRICKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7406794 ↗
• MalfunctionMar 7, 2018Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: "THE NEEDLE DID NOT ENTER THROUGH THE TEFLON AND HAD TO BE REMOVED THROUGH THE ENDOSCOPE CHANNEL AND BROKE IT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319709 ↗
• InjuryFeb 26, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PHYSICIAN DID EUS-FNB PROCEDURE AND HE MEASURED NEEDLE ADJUSTER 3 CENTIMETER TO PUNCTURE. HE FIXED AND HIT STROKE BUT THE NEEDLE PASSED THROUGH 6 CENTIMETER BECAUSE OF LOOSEN ADJUSTER. PATIENT BLED A LOT AND THE PHYSICIAN REMOVED THE NEEDLE RIGHT AWAY. JUST THE NEEDLE OUT OF THE SCOPE CHANNEL AND BEING REMOVED.

  Patient problems: No Code Available

  MAUDE report 7296268 ↗
• MalfunctionNov 6, 2017Bent; Kinked; Bent; Kinked

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. CLINICIAN HAD TROUBLE EXTENDING THE NEEDLE OUT OF THE SHEATH ON SECOND PASS. ON VISUAL ENDSCOPIC VIEW HE NOTICED THE NEEDLE TIP WAS BENT SO HE REMOVED THE FROM THE PATIENT WHILE THE NEEDLE WAS STILL DOWN THE SCOPE. ON FURTHER INVESTIGATION THE NEEDLE WAS BENT AT THE CORE TRAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003112 ↗
• MalfunctionJun 28, 2017Break; Break

  DURING A PUNCTURE UNDER ENDOSCOPIC ULTRASONOGRAPHY, THE BIOPSY NEEDLE BROKE IN THREE PIECES. NO PATIENT INJURY. FIRST PASSAGE FOR PUNCTURE OF THE TUMOR DO NO PROBLEM. SECOND PASSAGE FOR PUNCTURE: PLACING OF THE NEEDLE IN THE TUMOR WITH THE MANDREL IN THE NEEDLE. THE NURSE REMOVES THE MANDREL, THE DOCTOR PULLS ON THE NEEDLE'S WRIST AND THE NEEDLE BROKE INTO 3 PIECES.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6672847 ↗
• MalfunctionJun 27, 2017Break; Break

  THIS INITIAL MDR IS BEING SUBMITTED DUE TO THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF: PROXIMAL NEEDLE BREAKAGE NEEDLE DID NOT GO BACK AFTER SAMPLE TISSUE WAS TAKEN. "AS PER COMPLAINT FORM": AFTER THE ASPIRATION, THE NEEDLE COULD NOT RETRACTED IN TO THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669193 ↗
• MalfunctionFeb 23, 2017Bent; Bent

  THE NEEDLE TIP WAS NOTED TO BE BENT BEFORE USE. THE USER ATTEMPTED TO PUT THE DEVICE DOWN THE SCOPE, BUT COULD NOT GET THE NEEDLE INTO THE CORRECT POSITION. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6352393 ↗
• MalfunctionFeb 6, 2017Break; Break

  THE USER FELT RESISTANCE WHEN THEY PUNCTURED WITH THE DEVICE. THEY WITHDREW THE DEVICE AND ABOUT 3 CM DISTAL FROM TIP OF THE NEEDLE WAS FOUND TO BE DETACHED. NO PORTION WAS LEFT INSIDE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6303737 ↗
• MalfunctionDec 19, 2016Bent; Bent

  THE USER PUNCTURED THE ULTRASOUND BIOPSY NEEDLE INTO PELVIC TUMOR AND BEGAN TO PULL BACK. THE NEEDLE FAILED TO PULL BACK TO BIOPSY. THE DEVICE WAS WITHDRAWN FROM THE ENDOSCOPE. THE DEVICE WAS EXAMINED AND ABOUT 1.5CM OF THE DISTAL TIP OF NEEDLE WAS BENT. THEN USER TRIED TO RETRACT NEEDLE INTO SHEATH. TIP OF NEEDLE WAS DETACHED. THE SHEATH REFERENCE MARK COULD NOT BE ADJUSTED AT 0 MARK. REPLACE NEW DEVICE TO FINISH THE PROCEDURE. NO ADVERSE EVENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6184977 ↗
• MalfunctionAug 16, 2016Retraction Problem; Retraction Problem

  THIS INFORMATION WAS PROVIDED BY THE CUSTOMER TO THE COOK REPRESENTATIVE; AFTER THE NEEDLING, DR. (B)(6) FELT RESISTANCE WHEN TRYING TO RETRACT THE NEEDLE INTO THE SHEATH. THUS, HE WITHDREW THE NEEDLE TOGETHER WITH THE SCOPE. WHEN IT WAS OUTSIDE THE PATIENT, DR. (B)(6) NOTICED THAT THE NEEDLE WAS NOT FULLY RETRACTED INTO THE SHEATH EVEN THOUGH IT WAS LOCKED AT "0" ON THE HANDLE. HE PROCEEDED TO COLLECT THE SAMPLES. WHEN COMPLETE, HE TRIED TO RETRACT THE NEEDLE INTO THE SHEATH AGAIN AND WAS THEN ABLE TO DO SO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5878152 ↗
• MalfunctionJul 6, 2016Retraction Problem; Retraction Problem

  AFTER THE FIRST PASS, IT WAS NOTED THAT THERE WAS A BEND ON THE VERY TIP OF THE NEEDLE AND IT WAS NOT POSSIBLE TO RETRACT THE NEEDLE INTO THE SHEATH. ANOTHER ECHO DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5772086 ↗