EchoTip G31518Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002315181), received between Nov 15, 2017 and Jul 26, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2019Material Deformation; Material Deformation

  DURING A PUNCTURE WITH 20G NEEDLE, NURSE + SURGEON ENCOUNTER GREAT DIFFICULTY TO PULL THE WIRE GUIDE. THE TIP TO ALLOW THE GRIP ON THE WIRE GUIDE BROKE. DEVICE REMOVED AND CHANGED WITH A 22G NEEDLE: SAME ISSUE. RESISTANCE OF THE WIRE GUIDE AND SEPARATION OF THE TIP. A SMALL SAMPLE WAS RETRIEVED WITH THE 2ND NEEDLE, THE BIOPSY WAS STOPPED. THE TEAM EMPHASISES T GUIDES ARE MORE AND MORE DIFFICULT TO PULL, IT IS THE 1ST TIME THE TIP OF THE GUIDES BREAKS. "AS PER COMPLAINT FORM": DIFFICULTY TO PULL THE STYLET , THE TIP OF STYLET WAS BROKEN THE DEVICE WAS EVALUATED ON THE 28-JUN-19 CONFIRMING THE NEEDLE WAS KINKED PROXIMALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830511 ↗
• MalfunctionDec 13, 2018Break; Break

  AS PER CUSTOMER COMPLAINT FORM "WHILE DOING EUS-FNA, HANDLE OF EUS-FNA NEEDLE GOT DISENGAGED FROM THE ASSEMBLY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8159199 ↗
• MalfunctionJun 14, 2018Retraction Problem; Retraction Problem

  AS REPORTED TO CUSTOMER RELATIONS: "NEEDLES AND STICKING DURING ULTRASOUND PROCEDURES, WHEN TRYING TO ACTUATE THE NEEDLE THROUGH THE ENDOSCOPE AND OUT OF THE CATHETER. PROCEDURES COMPLETED BY USING ANOTHER DEVICE (MAY HAVE BEEN COOK, DIFFERENT GPN, MAY HAVE BEEN COMPETITOR DEVICE)." ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON (B)(6) 2018: "I WAS NOT IN THE CASES AND CUSTOMER REPORTED TO ME INFORMATION I IN TURN REPORTED TO YOU. CUSTOMER DOES NOT HAVE FURTHER DETAIL. I WISH I COULD BE OF MORE HELP." ADDITIONAL INFORMATION RECEIVED: "WAS THE NEEDLE FULLY RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT? UNKNOWN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600882 ↗
• MalfunctionJun 14, 2018Retraction Problem; Retraction Problem

  AS REPORTED TO CUSTOMER RELATIONS: "NEEDLES AND STICKING DURING ULTRASOUND PROCEDURES, WHEN TRYING TO ACTUATE THE NEEDLE THROUGH THE ENDOSCOPE AND OUT OF THE CATHETER. PROCEDURES COMPLETED BY USING ANOTHER DEVICE (MAY HAVE BEEN COOK, DIFFERENT GPN, MAY HAVE BEEN COMPETITOR DEVICE)." ADDITIONAL INFORMATION PROVIDED BY DM ON 24MAY2018: "I WAS NOT IN THE CASES AND CUSTOMER REPORTED TO ME INFORMATION I IN TURN REPORTED TO YOU. CUSTOMER DOES NOT HAVE FURTHER DETAIL. I WISH I COULD BE OF MORE HELP." ADDITIONAL INFORMATION RECEIVED "WAS THE NEEDLE FULLY RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT? UNKNOWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600803 ↗
• MalfunctionJun 14, 2018Retraction Problem; Retraction Problem

  AS REPORTED TO CUSTOMER RELATIONS: "NEEDLES AND STICKING DURING ULTRASOUND PROCEDURES, WHEN TRYING TO ACTUATE THE NEEDLE THROUGH THE ENDOSCOPE AND OUT OF THE CATHETER. PROCEDURES COMPLETED BY USING ANOTHER DEVICE (MAY HAVE BEEN COOK, DIFFERENT GPN, MAY HAVE BEEN COMPETITOR DEVICE)." ADDITIONAL INFORMATION PROVIDED BY DM ON 24MAY2018: "I WAS NOT IN THE CASES AND CUSTOMER REPORTED TO ME INFORMATION I IN TURN REPORTED TO YOU. CUSTOMER DOES NOT HAVE FURTHER DETAIL. I WISH I COULD BE OF MORE HELP." ADDITIONAL INFORMATION RECEIVED: "WAS THE NEEDLE FULLY RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT? UNKNOWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600766 ↗
• MalfunctionJun 14, 2018Retraction Problem; Retraction Problem

  AS REPORTED TO CUSTOMER RELATIONS: "NEEDLES AND STICKING DURING ULTRASOUND PROCEDURES, WHEN TRYING TO ACTUATE THE NEEDLE THROUGH THE ENDOSCOPE AND OUT OF THE CATHETER. PROCEDURES COMPLETED BY USING ANOTHER DEVICE (MAY HAVE BEEN COOK, DIFFERENT GPN, MAY HAVE BEEN COMPETITOR DEVICE)." ADDITIONAL INFORMATION PROVIDED BY DM ON 24MAY2018: "I WAS NOT IN THE CASES AND CUSTOMER REPORTED TO ME INFORMATION I IN TURN REPORTED TO YOU. CUSTOMER DOES NOT HAVE FURTHER DETAIL. I WISH I COULD BE OF MORE HELP." ADDITIONAL INFORMATION RECEIVED: "WAS THE NEEDLE FULLY RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT? UNKNOWN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600764 ↗
• MalfunctionNov 15, 2017Bent; Kinked; Bent; Kinked

  THIS FOLLOW UP MDR IS BEING SUBMITTED 30 DAYS FROM THE INITIAL REPORT TO INCLUDE DEVICE EVALUATION DETAIL UPDATES TO THE INVESTIGATION. THE NEEDLE IS BENT AND SHEATH DENTED. "AS PER COMPLAINT FORM": WHEN UNPACKING THE TEAM FOUND THAT THE SHEATH ADAPTER WASN'T EASY TO PUSH, WHEN LOOKING CLOSER THEY FOUND THE SHEATH SLIGHTLY BENT AND DENTED. THIS WAS THERE BEFORE UNPACKING THE NEEDLE. THEY TRIED TO PUSH THE NEEDLE THROUGH THE WORKING CHANNEL, BUT WITHOUT SUCCESS. THE STYLET COULD ONLY BE PULLED WITH RESISTANCE AND THEY WERE NOT ABLE TO REINSERT IT. A SECOND BEND (CLOSER TO THE TIP) HAPPENED, WHEN THEY REPACKED THE NEEDLE, SO IT HAS NOTHING TO DO WITH THIS COMPLAINT. ADDITIONAL INFORMATION RECEIVED 26OCT 2017"THE NEEDLE HASN'T BEEN USED IN THE PATIENT. IN THIS HOSPITAL THEY ARE INTRODUCING THE NEEDLE IN THE WORKING CHANNEL BEFORE THEY INTRODUCE THE SCOPE IN THE PATIENT. THEY FOUND THE FIRST KINK (THE ONE BELOW THE SHEATH ADJUSTOR) WHEN UNPACKING THE NEEDLE AND FOUND IT HARD TO MOVE THE STYLET. THE SECOND KINK (CLOSE TO THE DISTAL END OF THE NEEDLE) HAPPENED WHEN THEY TRIED TO REPACK THE NEEDLE IN THE PACKAGING AFTER THEY FOUND OUT IT WAS NOT USABLE. " ADDITIONAL INFORMATION RECEIVED -

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7032790 ↗