EchoTip G52012Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002520127), received between Feb 19, 2016 and Aug 28, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 1, 2024Open, Classified

   Devices may contain elevated levels of bacterial endotoxin.

   Z-1832-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionAug 28, 2025Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

  NEEDLE COULDN'T BE EXTENDED. "AS PER CC FORM": THE NEEDLE-SYSTEM WAS PUSHED THROUGH THE EUS-DEVICE UNTIL THE SHEATH-TIP WAS OUT OF THE DEVICE. THE NEEDLE ITSELF COULD THEN ONLY BE PUSHED OUT WITH THE GREAT RESISTANCE, AND THE SHEATH WAS PERFORATED. A SECOND NEEDLE WAS THEN INSERTED WITHOUT DIFFICULTY, AND THE INTERVENTION WAS SUCCESSFULLY. 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.) FROM THE STOMACH TO THE LEFT INTRAHEPATIC BILE DUCT. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. FROM THE STOMACH TO THE DHC, APPROX. 5 CM. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO. YES. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? YES. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. NO. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? N/A, YES, NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO. NO. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO. NO. 10. WHEN WAS THE ISSUE NOTED? E.G., ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919933 ↗
• MalfunctionDec 10, 2019Material Twisted/Bent; Material Twisted/Bent

  NEEDLE TIP WAS BEND. RESULT OF THIS DEFECT APPLIANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443156 ↗
• MalfunctionOct 3, 2019Material Perforation; Material Perforation

  USER ADVANCE THE DEVICE TO STOMACH BUT FOUND OUT THE NEEDLE CANNOT BE ADVANCED FROM SHEATH. USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THE TIP OF NEEDLE SLIGHTLY BENT WHICH CAUSE THE ADVANCEMENT DIFFICULTY. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. DEVICE WAS RETURNED AND EVALUATED ON 04-SEP-2019 AND THE TIP OF THE SHEATH WAS NOTED TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149660 ↗
• MalfunctionJul 30, 2019Material Perforation; Material Perforation

  THE DOCTOR INSERTED THE ECHO-HD-19-A THROUGH THE SCOPE. HE ADJUSTED THE ANGLE AND PUSHED THE HANDLE TO PUNCTURE. HOWEVER, THE HANDLE WAS NOT PRESSED WELL AND THE NEEDLE DID NOT COME OUT EITHER. THE NURSE PULLED THE ECHO-HD-19-A OUT AND FOUND THAT SHEATH WAS BROKEN. THE END OF THE SHEATH WAS HANGING BROKEN. THE DOCTOR GUESSED THE CAUSE OF THE SHEATH BEING BROKEN - WHEN HE PUSHED THE HANDLE, THE NEEDLE PIERCED THE BENT SHEATH. SO SHEATH WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842055 ↗
• MalfunctionJan 9, 2019Fracture; Material Deformation; Fracture; Material Deformation

  THE DOCTOR TRIED THE EUS - PSEUDOCYST DRAINAGE. SO HE PUNCTURED TO THE TARGET BY USING ECHO-HD-19-A. AND INSERTED GUIDE WIRE THROUGH THE NEEDLE. AND REMOVED THE ECHO-HD-19-A. BUT GUIDE WIRE WAS MISSED, CAME OUT. SO HE HAD TO USE ECHO-HD-19-A,. BUT, THE NURSE REALIZED THE SHEATH TIP WAS BENT, AND TOUCHED IT. THEN, TIP WAS BROKEN. SO, THEY USED A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8231786 ↗
• MalfunctionDec 12, 2018Break; Break

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. AS INITIALLY REPORTED TO CUSTOMER RELATIONS : DURING AN EUS CYSTGASTROESTOMY PROCEDURE THE ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, G52012, WAS USED. THE PHYSICIAN DID NOT REPOSITION STYLET FOR REPUNCTURING. THE SHEATH SNAPPED FROM THE SHEATH. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; UNKNOWN WHAT MANUFACTURE AND DEVICE. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155717 ↗
• MalfunctionSep 26, 2018Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  UPON ADVANCE THE NEEDLE THROUGH THE SHEATH, RESISTANCE WAS MET, AND THE NEEDLE DAMAGED THE END OF THE SHEATH AND DAMAGED THE SCOPE. THE SCOPE NOW HAS A LEAK. THE TECH OPENED TWO MORE TO TEST AND BOTH HAD DIFFICULTY ADVANCING, SO THESE TWO DEVICES WERE NOT USED AND WERE DISCARDED. THESE TWO DEVICES DID NOT MAKE ENDOSCOPE OR PATIENT CONTACT. THE TECH MENTIONED THAT THE ELEVATOR MAY HAVE COME DOWN TOO HARD ON THE DEVICE WHERE THE RESISTANCE WAS MET; HOWEVER, THE OTHER TWO DEVICES WHICH WERE TESTED HAD A SIMILAR ISSUE, SO THIS THEORY DID FIT FOR ALL DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910282 ↗
• MalfunctionOct 3, 2017Break; Break

  PRODUCT FOUND DAMAGED AFTER OPENING THE PACKET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6909940 ↗
• MalfunctionAug 31, 2017Break; Break

  THIS INITIAL MDR IS BEING SUBMITTED AS THE NEEDLE WAS RECEIVED BROKEN ON RETURN. DOCTOR COULD NOT VIEW THE DEVICE UNDER ULTRASOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6834276 ↗
• MalfunctionMay 17, 2017Material Perforation; Material Perforation

  A FOLLOW UP MDR IS BEING SUBMITTED A THE DEVICE WAS RETURNED AND EVALUATED. PROBLEM IS THAT NEEDLE COULDN'T SLIDE CORRECTLY IT WAS REALLY DIFFICULT TO USE THE STYLET. THEY PERFORATED THE NEEDLE PLASTIC SHEATH. "AS PER COMPLAINT FORM": CUSTOMER FORGET TO DECLARE THE COMPLAINT END OF LAST YEAR 2016, THEY DID IT ONLY IN (B)(6) 2017 WE DON'T HAVE MUCH DETAILS OF PROBLEM, JUST WHAT I DESCRIBED IN MY FIRST EMAIL PROBLEM IS THAT THE NEEDLE COULDN'T SLIDE CORRECTLY, IT WAS VERY DIFFICULT TO USE. THEY PERFORATED THE PLASTIC SHEATH WITH NEEDLE STYLET NO MORE DETAILS BECAUSE IT HAPPENED FOR A LONG TIME, DR FORGET THIS PROBLEM. NO PROBLEM WITH PATIENT AND SCOPE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571570 ↗
• InjuryMay 3, 2017Break; Break

  NEEDLE BROKEN DURING THE PUNCTURE. CC FORM. DR (B)(6) STARTED A PROCEDURE OF A BULBO CHOLEDOCOTOMY, PUNCTURE OF BILE DUCT THROUGH THE BULB. FIRST TIME IN WRONG POSITION, REMOVED THE NEEDLE. SECOND TIME, PLACE THE NEEDLE IN STRAIGHT POSITION SCOPE, BOW THE SCOPE AND USE ELEVATOR TO HAVE A CORRECT AXES, TRY TO PUSH THE NEEDLE AND THIS WAS BROKEN INSIDE THE SCOPE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6540137 ↗
• MalfunctionMar 2, 2017Bent; Bent

  THE NEEDLE WAS ADVANCED DOWN THE SCOPE, WHICH WAS IN A TORQUED POSITION, AND WHEN ADVANCED THE NEEDLE IT STARTED COMING OUT OF THE SIDE OF THE SHEATH INSTEAD OF THE END. PER THE (B)(6): "NO REPORTED RETRACTION ISSUE. HOWEVER, DAMAGE TO THE SHEATH WAS CAUSED BY THE BENT NEEDLE TIP ON 1 OF THE RETURNED DEVICES." I.E. THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372014 ↗
• InjuryJan 5, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF NEEDLE WAS DETACHED INSIDE PATIENT'S COMMON BILE DUCT. THEY TOOK OUT THE DETACHED PART IMMEDIATELY. THE PATIENT WAS TRANSFERRED TO SURGERY OFFICE TO TREAT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6224680 ↗
• MalfunctionDec 20, 2016Device Operational Issue; Device Operational Issue

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS AND INVESTIGATION CONCLUSIONS. INITIAL COMPLAINT DETAILS: IT WAS REPORTED THAT DURING THE USE OF THE ECHOTIP NEEDLE, THE PROTECTIVE SHEATH OF THE NEEDLE PERFORATED, MAKING IT IMPOSSIBLE TO USE. CONSEQUENCE WAS A WASTE OF TIME DURING PROCEDURE AND ECONOMIC CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188566 ↗
• InjuryOct 4, 2016Break; Break

  IT WAS REPORTED THAT THE DOCTOR TRIED TO PRICK INTO THE CYST, THE NEEDLE BENT AND BROKE. THE BROKEN PIECE WAS RECOVERED. A NEW NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5995922 ↗
• MalfunctionAug 15, 2016Device Operational Issue; Device Operational Issue

  PRODUCT WAS PASSED THROUGH THE EUS LINEAR OLYMPUS SCOPE AND WAS EXTENDED FROM THE END OF THE SCOPE. ON INSPECTION, IT WAS FOUND THE TIP OF THE SHEATH HAD BROKEN OFF. THE BROKEN PIECES WAS COLLECTED AND PLACED INTO A CONTAINER TO BE SENT BACK WITH THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5875234 ↗
• MalfunctionJul 20, 2016Break; Break

  THIS IS A FOLLOW UP REPORT DUE TO THE COMPLETION OF THE INVESTIGATION. AFTER FAILING TO DRAIN THE TARGETED CYST USING THE EUS LINEAR ENDOSCOPE AND THE ECHO PRODUCT, THE PHYSICIAN TOOK OUT THE PRODUCT AND FOUND THAT THE SHEATH AND THE NEEDLE WERE DISCONNECTED. NO COMPONENT REMAINED IN THE PATIENT'S BODY AND THE PROCEDURE WAS SUCCESSFUL USING A NEW ECHO PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5808320 ↗
• MalfunctionFeb 19, 2016Break; Break

  WHEN DOCTOR TRIED TO PUNCTURE THE CYST,NEEDLE BENT AND DID NOT PENETRATE THE CYST. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THE NEEDLE WAS BROKE WHICH IS A MALFUNCTION PRECEDENCE FOR THIS PRODUCT FAMILY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5448933 ↗