EchoTip G31519Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002315198), received between Apr 12, 2016 and Feb 14, 2020 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Material Twisted/Bent; Material Twisted/Bent

  WHEN PACKAGE WAS OPEN, STYLET WAS ALREADY OUT OF PLACE. WENT AHEAD TO CHECK, THE FNA SHIFT WAS BENT (THE POINT CONNECTING FNA SHIFT AND HANDLE). UNABLE TO PUSH STYLET IN AS WELL. STYLET KINKED WHEN IT WAS RE-INSERTED AFTER PULLING OUT. DEVICE WAS RETURNED AND EVALUATED ON 16-JAN-2020 AND A KINK WAS NOTED BELOW THE SHEATH EXTENDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710579 ↗
• MalfunctionNov 12, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS HEAD OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-25 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T COME OUT OF THE NEEDLE SHEATH. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. THEY USED ANOTHER ECHO-25.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308989 ↗
• MalfunctionAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DURING USE IN THE MEDIASTINUM LYMPHATIC AREA, THE NEEDLE IS DIFFICULT TO ADVANCE AT THE LAST 2-3 CM. THE USER HAS TO FORCIBLY APPLY PRESSURE TO GET THE NEEDLE TO EXIT. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THIS DEVICE WITH NO PATIENT HARM. THIS USER STATED THIS HAS OCCURRED MULTIPLE TIMES IN THE LAST WEEK - AN ADDITIONAL COMPLAINT WAS OPENED TO INVESTIGATE THIS ISSUE. COMPLAINT DEVICE WAS EVALUATED ON 31-JUL-2019 AND A PROXIMAL KINK WAS OBSERVED BELOW THE SHEATH EXTENDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944460 ↗
• MalfunctionJul 24, 2019Material Twisted/Bent; Material Twisted/Bent

  THE NEEDLE WAS BENT AFTER JUST ONE USE IN DUODENUM FOR DIAGNOSIS PANCREATIC CANCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822361 ↗
• MalfunctionJul 10, 2019Material Twisted/Bent; Material Twisted/Bent

  DIRECT QUOTE FROM COMPLAINT FORM: "LINEAR ECHOENDOSCOPE ADVANCED INTO DUODENAL BULB. LESION IDENTIFIED ENDOSONOGRAPHICALLY. EUS FNA NEEDLE WAS INSERTED AND LUER-LOCKED INTO ECHOENDOSCOPE. ATTEMPTS TO ADVANCE THE NEEDLE OUT OF SHEATH WERE UNSUCCESSFUL. EUS FNA NEEDLE WAS WITHDRAWN." DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED ON 12-JUN-2019. NEEDLE WAS NOTED TO HAVE CRUMBLED IN THE HANDLE - OVERALL RISK ASSESSED AS CATEGORY IIB (MODERATE). 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 8775725 ↗
• MalfunctionJun 4, 2019Break; Break

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 78 YEAR OLD FEMALE UNDERWENT AN EUS IN PANCREAS PROCEDURE IN WHICH THE ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE, G31519, WAS USED. TWO EUS NEEDLES DIDN'T PERFORM AS EXPECTED. FIRST EUS NEEDLE INSERTED INTO SCOPE AND TISSUE REMOVED FROM NEEDLE. ON SUBSEQUENT MULTIPLE PASSES, THE SHEATH MOVED SEPARATE FROM THE CONTROLS ON THE SHAFT/LOCK KNOBS (G263197). SWITCHED TO SECOND EUS NEEDLE WITH SAME LOT NUMBER AND FIRST PASS COMPLETED BUT UNABLE TO RETRIEVE SPECIMEN (PR263209). STYLET WOULDN'T INSERT INTO TOP OF NEEDLE AND TECH ATTEMPTED TO USE SYRINGE WITH AIR AND AIR ESCAPED AT BOTTOM OF NEEDLE. DR. KYANAM FEARED NEEDLE WAS BROKEN AND SPECIMEN LEFT IN NEEDLE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿"PROXIMAL/DISTAL NEEDLE BREAKAGE" AS THE PHYSICIAN FEARED THE NEEDLE WAS BROKEN. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8665886 ↗
• MalfunctionApr 12, 2019Failure to Advance; Failure to Advance

  THEY CHECKED THAT MASS LOCATION WAS UNCINATE PROCESS OF PANCREAS BEFORE THE PROCEDURE. THEY ADVANCED ECHO-25 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T ADVANCE OUT OF THE NEEDLE SHEATH. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8507679 ↗
• MalfunctionMar 6, 2019Difficult to Advance; Difficult to Advance

  IMPOSSIBLE TO TAKE OUT THE STYLET & IMPOSSIBLE TO ADVANCE THE NEEDLE. AS PER COMPLAINT FORM : "IT IS IMPOSSIBLE TO GET INSIDE THE LESION AND ALSO IMPOSSIBLE TO PUT THE STYLET BACK INSIDE THE NEEDLE UNTIL THE END OF THE NEEDLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394598 ↗
• MalfunctionMar 6, 2019Break; Break

  IT IS IMPOSSIBLE TO PUNCTION THE LESION. THE NEEDLE BROKE, AT THE PROXIMAL END WHERE THE NEEDLE CRUMBLED IN THE HANDLE DURING THE DEVICE EVALUATION ON 06-FEB-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8393925 ↗
• MalfunctionFeb 19, 2019Difficult to Advance; Difficult to Advance

  IT IS IMPOSSIBLE TO PUT THE STYLET BACK INTO THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349228 ↗
• MalfunctionJan 8, 2019Material Deformation; Material Deformation

  THE PHYSICIAN DID THE PUNCTURE TO MASS TO OBTAIN CORE TISSUE. HOWEVER IT BENT A LOT AND FROM THE 2ND PUNCTURE, IT COULDN'T PUSH FORWARD AT ALL. HE PAUSED THE PROCEDURE AND USED ECHO-3-22 AND PROCEDURE FINISHED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8225705 ↗
• MalfunctionDec 18, 2018Material Deformation; Material Deformation

  "NEEDLE WAS BENT COMING OUT OF THE PACKAGING" WILL BE RETURNED. NOT USED. LOT CONFIRMED. "AS PER COMPLAINT FORM": NURSE OPENED PACKAGE AND NOTICED THE NEEDLE WAS BENT/KINKED. TRIED TO BEND IT BACK HOWEVER DOCTOR REFUSES TO USE THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172785 ↗
• MalfunctionSep 25, 2018Material Deformation; Material Deformation

  AS REPORTED TO CUSTOMER RELATIONS, "IT CAME OUT OF THE PACKAGE WITH A KINK IN THE SHEATH AND THE NEEDLE WOULD NOT ADVANCE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906154 ↗
• MalfunctionSep 19, 2018Break; Break

  USER FINISHED THE BIOPSY AT DESCENDING PORTION OF DUODENUM. THE TARGET AREA IS RELATIVELY STIFF. USER RETRACTED THE DEVICE FROM PATIENT AND ENDOSCOPY AND WAS GOING TO GET THE TARGET SAMPLE WHILE THE HEAD OF THE BIOPSY NEEDLE DETACHED FROM THE DEVICE. SEE ATTACHED PICTURE. USER USE ECHO-3-22 TO FINISH THE BIOPSY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888625 ↗
• MalfunctionNov 9, 2017Bent; Kinked; Bent; Kinked

  AS REPORTED TO CUSTOMER RELATIONS, "BOTH WERE USED IN THE SAME PROCEDURE. BOTH HAD THE SAME COMPLAINT. AFTER JUST ONE PASS, THE STYLET WOULD NOT PASS ALL THE WAY THROUGH THE NEEDLE-IT BECAME STUCK NO MATTER HOW STRAIGHT THE SHEATH WAS KEPT OR HOW CLEAN THE ASSISTANT MADE THE NEEDLE WITH SALINE FLUSH AND AIR AFTER THE SPECIMEN WAS COLLECTED. (NEEDLE # 1) HAD 1-2 CM LEFT BEFORE BEING FULLY SEATED AND IT WOULD NOT EXIT THE TIP OF THE NEEDLE. ANOTHER COOK 25G NEEDLE WAS USED FOR THE 2ND PASS AND THE STYLET PASSED WITH NO PROBLEM. - (B)(4). (NEEDLE # 2) AFTER 1 PASS THE STYLET WAS ONLY ABLE TO PASS THROUGH ABOUT 25 CM BEFORE IT BECAME STUCK AND HAD TO BE PULLED WITH GREAT FORCE TO REMOVE IT. THE STYLET LOOKED AND FELT LIKE IT HAD BEEN "ROUGHED UP" WHEN IT WAS STUCK INSIDE THE NEEDLE. - (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7014082 ↗
• MalfunctionSep 27, 2017Bent; Bent

  THIS REPORT FORMS A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOLLOWING UPDATE TO THE RISK CATEGORY FOR THIS FAILURE MODE. AS REPORTED TO CUSTOMER RELATIONS, "AFTER THE 2ND OR 1ST PASS THE STYLET WAS NOT ABLE TO PASS. THEY SAID THAT WAS THE SECOND NEEDLE WITH THE SAME ISSUE BUT THEY DID NOT SAVE IT. PATIENT DID GOOD AFTER THE PROCEDURE, NO HARM, USED DIFFERENT NEEDLE TO "FINISH" THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6897157 ↗
• MalfunctionSep 22, 2017Bent; Bent

  AS REPORTED TO CUSTOMER RELATIONS: "DURING AN EUS PROCEDURE THE ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE WAS USED. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE NEEDLE. IT WAS REMOVED AND ANOTHER OF THE SAME LOT NUMBER WAS USED. THIS NEEDLE ALSO WOULD NOT ADVANCE ((B)(4)). A THIRD NEEDLE FROM LOT# C1334254 WAS USED WHICH ALSO WOULD NOT ADVANCE ((B)(4)). THIS DEVICE WAS REMOVED AND THE PHYSICIAN USED A BOSTON NEEDLE TO COMPLETE THE PROCEDURE. " THIS REPORT RELATES TO 1 X ECHO-25 DEVICE OF LOT # C1353510 USED DURING THE ABOVE PROCEDURE. THIS DEVICE WAS EVALUATED ON THE 25 AUG 17 AND THE NEEDLE WAS CONFIRMED TO BE CRUMPLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886445 ↗
• MalfunctionSep 22, 2017Failure to Advance

  AS REPORTED TO CUSTOMER RELATIONS: "DURING AN EUS PROCEDURE THE ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE WAS USED. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE NEEDLE. IT WAS REMOVED AND ANOTHER OF THE SAME LOT NUMBER WAS USED. THIS NEEDLE ALSO WOULD NOT ADVANCE ((B)(4)). A THIRD NEEDLE FROM LOT# C1334254 WAS USED WHICH ALSO WOULD NOT ADVANCE ((B)(4)). THIS DEVICE WAS REMOVED AND THE PHYSICIAN USED A BOSTON NEEDLE TO COMPLETE THE PROCEDURE. " THIS REPORT INVOLVES 1 X ECHO-25 DEVICE OF LOT # C1334254. THE DEVICE INVOLVED IN THIS EVENT WAS EVALUATED AND THE NEEDLE WAS CONFIRMED TO BE CRUMPLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886438 ↗
• MalfunctionMar 10, 2017Kinked; Kinked

  AS REPORTED TO CUSTOMER RELATIONS, "THE DEVICE WOULD NOT COME OUT OF THE SCOPE CHANNEL WHEN IT'S SENT DOWN THE SCOPE. THIS DEVICE WAS REMOVED AND A COMPETITORS DEVICE (22 GAUGE) WAS USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6394701 ↗
• MalfunctionMar 1, 2017Bent; Kinked; Bent; Kinked

  AS REPORTED TO CUSTOMER RELATIONS, "WHEN THE DEVICE IS TAKEN OUT OF THE PACKAGE, THE CUSTOMER HAS BEEN NOTICING OVER THE PAST MONTH OR SO THE NEEDLE SHEATH HAS BEEN BENT AT THE BRASS LUER LOCK FITTING. IT'S ALMOST BENT IN A 90 DEGREE ANGLE RIGHT OUT OF THE PACKAGE. THE CUSTOMER THINKS ITS GETTING BENT WHEN COOK PLACES INSIDE THE PACKAGE FOR DISTRIBUTION. THE CUSTOMER HAS INDICATED SHE HAS ONLY NOTICED THIS WITH THE 25G NEEDLE. THE BEND MAKES SHEATH ADJUSTMENT DIFFICULT. THE BEND PREVENTS REINSERTION OF THE STYLET. SOMETIMES A NEW NEEDLE HAS TO BE OPENED TO COMPLETE THE INTENDED PROCEDURE. IN TODAY'S CASE, THE DOCTOR JUST USED THE NEEDLE WITHOUT A STYLET AND COMPLETED THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6367577 ↗
• MalfunctionMay 17, 2016Device Operational Issue; Device Operational Issue

  THIS EVENT WAS INITIALLY ASSESSED AS FDA MDR REPORTABLE BASED ON A CONSERVATIVE ASSESSMENT THAT THIS EVENT MET THE CRITERIA OF AN MDR 'MALFUNCTION REPORT'. FOLLOWING THE SUBMISSION OF THE INITIAL REPORT THE RISK OF THIS EVENT AND FAILURE MODE WAS EVALUATED RESULTING IN A LOW RISK RATING FOR THIS EVENT AND FAILURE MODE. IT MAY BE NOTED ALSO THAT NO INJURY TO THE PATIENT HAS BEEN REPORTED AS A RESULT OF THIS EVENT. IT IS ALSO NOTED THAT A REPORTING MALFUNCTION PRECEDENCE DOES NOT EXIST FOR THIS FAILURE MODE. BASED ON THE RISK ASSESSMENT CARRIED OUT RELATING TO THIS EVENT - THIS EVENT IS NO LONGER FDA MDR REPORTABLE AND DOES NOT MEET THE CRITERIA OF AN FDA MDR 'MALFUNCTION' REPORT AS PER FDA GUIDELINES 'MEDICAL DEVICE REPORTING FOR MANUFACTURERS'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5659800 ↗
• InjuryApr 12, 2016Break; Break

  DOCTOR REPORTED THAT HE HAD THE TIP OF THE ECHO NEEDLE BREAK INSIDE THE LIVER. HE WAS UNABLE TO RETRIEVE THE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 5569325 ↗