EchoTip ProCore G55736Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002557369), received between Jul 29, 2016 and Dec 12, 2019 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 THE NEEDLE WAS RETRACTED BACK INTO THE SHEATH, THE DOCTOR ATTEMPTED A SECOND PUNCTURE BUT FAILED BECAUSE THE NEEDLE WAS UNABLE TO COME OUT FROM THE SHEATH.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 ↗
• MalfunctionJun 13, 2019Retraction Problem; Retraction Problem

  DURING THE EUS WITH BIOPSY, THE ECHOTIP PROCORE NEEDLE WAS USED. BEFORE THE SURGERY, THE NEEDLE WAS CHECKED, BOTH THE PACKAGING AND THE NEEDLE ITSELF WERE INTACT. AFTER THE BIOPSY THERE WERE SOME DIFFICULTIES RELATED TO THE WITHDRAWAL OF THE NEEDLE FROM THE BIOPSY CHANGE - THERE WAS NO POSSIBILITY OF RETURNING THE HANDLE TO THE "ZERO" POSITION, AND THERE WAS A SENSE OF SPRINGING ON THE HANDLE (BETWEEN POSITION 1 AND 0) AT THAT TIME THE NEEDLE REVEALED IN THE ULTRASOUND IMAGE AS STILL EXTENDED AND DRIVEN INTO A CHANGE. WITH GREAT DIFFICULTY, THE NEEDLE WAS REMOVED FROM THE CHANGE AND WITHDRAWN FROM THE BIOPSY CHANNEL. AFTER REMOVING THE NEEDLE FROM THE ENDOSCOPE, IT TURNED OUT THAT THE TIP OF THE NEEDLE DID NOT HIDE INTO THE CASING - AN EXTENDED AND FOLDED SECTION OF APPROX. 5 MM WAS INSERTED, CAUSING THE ENDOSCOPE CANAL TO BE SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695656 ↗
• MalfunctionDec 17, 2018Material Deformation; Material Deformation

  DURING THE FIRST BIOPSY, USER CANNOT PULL THE NEEDLE OUT. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168714 ↗
• MalfunctionJul 27, 2018Material Deformation; Material Deformation

  AN FNA PROCORE NEEDLE HAPPENED TO "BREAK" ON THE LEVEL OF THE UPPER HANDLE DURING THE PROCEDURE. A NEW NEEDLE HAVE BEEN OPENED AND USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726175 ↗
• MalfunctionMar 12, 2018Bent; Kinked; Bent; Kinked

  NEEDLE KINKED, VERY DIFFICULT TO TAKE THE SAMPLE BECAUSE STYLET COULDN¿T BE INTRODUCE CUSTOMER SUCCEED TO TAKE THE SAMPLE WITH WATER AND STOPPED EXAMINATION AFTER ONLY ONE PASSAGE. NO PROBLEM FOR THE PATIENT "AS PER COMPLAINT FORM": NURSE OPENED THE NEEDLE PACKAGE AND REMOVED IT FROM THE BOX WITHOUT PROBLEM. DR CONNECTED NEEDLE ON THE SCOPE IT WAS A LITTLE DIFFICULT BECAUSE HE WAS IN A DIFFICULT POSITION INTO DUODENAL BULB DOCTOR "PUNCTIONNED", AND REMOVED THE NEEDLE FROM THE SCOPE. THEY TRIED TO TAKE THE SAMPLE BUT NEEDLE WAS IMPOSSIBLE TO SLIDE INTO THE SHEATH; THE HANDLE MOVED BUT THE NEEDLE TIP STAYED FIXED. THEY COULD INSET THE STYLET INSIDE AND THEY DECIDED TO PUSH WATER INSIDE THE NEEDLE FOR PUSHING THE SAMPLE INTO THE POT, THEY COULD OBTAIN MATERIAL INTO THE POT AND DECIDED TO STOP EXAMINATION. FOR THE CUSTOMER THE NEEDLE IS DISCONNECTED FROM THE HANDLE. NO PROBLEM FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330840 ↗
• MalfunctionDec 4, 2017Bent; Bent

  THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE DEVICE WAS RETURNED FOR EVALUATION AND THE INVESTIGATION WAS UPDATED. THE NEEDLE WAS FOUND TO BE DISTORTED WHILE THE FIRST ATTEMPT OF PUNCTURE. A PICTURE OF THE BENT NEEDLE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7078970 ↗
• MalfunctionOct 12, 2017Bent; Retraction Problem; Material Perforation; Bent; Retraction Problem; Material Perforation

  THIS FOLLOW UP MDR IS DUE TO BE SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED. THE USER PUNCTURED WITH THE DEVICE AND PULLED UP THE NEEDLE ABOUT TEN TIMES. THEN THEY FELT A LITTLE RESISTANCE WHEN RETRACTING THE NEEDLE BACK SHEATH. THEY FOUND THAT TIP OF NEEDLE WAS BENT WHEN THEY HANDLED THE SAMPLE. REPLACE NEW DEVICE TO PUNCTURE THE SECOND TIME. ADDITIONAL INFORMATION RECEIVED ON THE 12 OCT 17 CONFIRMED THE SHEATH WAS PERFORATED BUT THE USER CANNOT DETERMINE WHETHER THE PERFORATION WAS DONE BY THE NEEDLE REVERSE BEVEL OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6943407 ↗
• MalfunctionAug 15, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  PROCORE 22 ECHO TIP NEEDLE WAS FOUND KINKED IN THE BOX PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6794319 ↗
• MalfunctionMay 30, 2017Bent; Packaging Problem; Bent; Packaging Problem

  UPON OPENING USER NOTICED THAT THE SHEATH WAS BENT AND COULD NOT BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6597675 ↗
• MalfunctionMay 25, 2017Break; Break

  THIS INITIAL MDR IS BEING SUBMITTED AS THE OVERALL RISK WAS ASSESSED AS MODERATE. THE RISK IS NOT CONSIDERED TO BE 'REMOTE'. AS REPORTED TO CUSTOMER RELATIONS: "THE NEEDLE LOCK WOULDN'T WORK, WHICH CAUSED THE ENTIRE NEEDLE TO COME OUT INSTEAD OF DESIRED LENGTH." DISTRICT MANAGER CONFIRMED VIA EMAIL THE NEEDLE ADJUSTER WOULD NOT WORK. THE SHEATH ADJUSTER WORKED FINE. TH 11MAY2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590373 ↗
• MalfunctionApr 7, 2017Retraction Problem; Retraction Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE USER ADVANCED THE DEVICE THROUGH ENDOSCOPE CHANNEL TO REACH DESIRED POSITION. PUNCTURE INTO PANCREAS. THEN NEEDLE COULD NOT ADVANCE AND RETRACT BACK TO SHEATH. WITHDRAW THE DEVICE FROM THE CHANNEL. THEN ABOUT 2 CM FROM TIP OF NEEDLE WAS FOUND BENT . REPLACE NEW DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6471154 ↗
• MalfunctionMar 7, 2017Retraction Problem; Retraction Problem

  THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED. UPON ENTERING THE LESION/MASS THE NEEDLE WAS EXTREMELY DIFFICULT TO ACTUATE. THE NEEDLE WAS RETRACTED, BUT WOULD NOT RETRACT FULLY INTO THE SHEATH; STUCK OUT APPROXIMATELY 3MM. THE NEEDLE WAS REMOVED AND A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6384050 ↗
• MalfunctionFeb 7, 2017Retraction Problem; Retraction Problem

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. INITIAL REPORT DETAILS: THE NEEDLE BENT. IT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE NEEDLE HAD TO BE CUT SO THAT IT WOULD NOT DAMAGE THE SCOPE AS IT WAS REMOVED. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿NON-RETRACTION' OF THE NEEDLE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306660 ↗
• MalfunctionNov 14, 2016Defective Component; Defective Component

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE THUMBSCREW WHICH IS SUPPOSED TO BLOCK THE NEEDLE IS NOT WORKING. THE NURSE OPENED THE PACKAGE AND CHECKED NEEDLE, IT WAS NOT OK. THEY COULD NOT ADJUST AND FIX THE CATHETER SHEATH PART, THE WHEEL SEEMED BROKEN. THEY TOOK A SECOND NEEDLE AND NO PROBLEM APPEARED. NO PROBLEM WITH PATIENT OR ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6098428 ↗
• MalfunctionSep 28, 2016Break; Break

  THE DISTAL NEEDLE BROKE AFTER BEING REMOVED FROM THE PATIENT, IT WAS COLLECTED DURING SAMPLE COLLECTION AND THE PATIENT DID NOT REQUIRE SURGERY OR ANY OTHER PROCEDURE AS A RESULT. THE DOCTOR REPLACED THE NEEDLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5983345 ↗
• MalfunctionSep 20, 2016Detachment Of Device Component; Defective Component; Detachment Of Device Component; Defective Component

  EUS-FNA FOR SMT WAS PERFORMED. THE DEVICE WAS NOT NOTABLY ANGLED, THE USER PUNCTURED THE TARGET SITE FROM THE STOMACH. HOWEVER, THE SCREW OF THE SLIDING SHEATH ADJUSTER WOULD NOT TIGHTEN ENOUGH WHICH CAUSED DIFFICULTY IN STROKING. SO THE PHYSICIAN REPLACED IT WITH ANOTHER ECHO-HD-22-C TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5962848 ↗
• MalfunctionJul 29, 2016Device Operational Issue; Device Operational Issue

  THE USER EXPERIENCED DIFFICULTY IN ADVANCING THE NEEDLE AFTER THE FIRST PUNCTURE OF THE PANCREATIC BODY THROUGH THE STOMACH. THE USER SUSPECTED THE BREAKAGE OF THE NEEDLE AND REPLACED WITH ANOTHER NEEDLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5833005 ↗