EchoTip G31521Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00827002315211), received between Mar 11, 2016 and Sep 8, 2026 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Bent” (22 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671689 ↗
• MalfunctionOct 24, 2025Material Fragmentation; Material Fragmentation

  DURING A PANCREAS BIOPSY, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. IT WAS INITIALLY REPORTED THAT AFTER PUNCTURING ONE (1) TIME. PENETRATION OF THE TARGETED SITE WAS DIFFICULT AND THE NEEDLE BECAME TIGHTER AND THE NEEDLE WAS NOT SMOOTH, AND THE PUNCTURE WAS STILL THE SAME. THE USER THEN TOOK IT OUT OF THE BODY AND TRIED TO FIND THAT IT WAS STILL VERY TIGHT. AFTER THAT, THE USER REPLACED THE ULTRASOUND BIOPSY NEEDLE WITH A NEW ONE TO CONTINUE THE TREATMENT. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 01OCT2025 AND THE NEEDLE WOULD NOT RETRACT. [SUBJECT OF REPORT] A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379603 ↗
• MalfunctionDec 18, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC ULTRASOUND, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. AFTER ONE (1) PASS THE PHYSICIAN NOTICED THE NEEDLE GAVE ISSUES [DIFFICULTY MOVING IN AND OUT OF THE SHEATH]. THE NEEDLE WAS REMOVED TO AVOID PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK ECHOTIP NEEDLE WITH NO FURTHER ISSUES. THIS EVENT WAS NOT REPORTABLE AT THE TIME. THE DEVICE WAS RECEIVED ON 22-NOV-2019 AND THE NEEDLE WAS BROKEN WITHIN THE HANDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490561 ↗
• MalfunctionAug 6, 2019Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND PULLED OUT PART OF THE INNER WIRE. THE USER FOUND OUT THE NEEDLE CANNOT BE RETRACTED INTO SHEATH AFTER FIRST ATTEMPT OF BIOPSY. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866789 ↗
• MalfunctionJun 7, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. AN EUS WAS PERFORMED. WHEN HE TRIED TO RETRACT THE NEEDLE, IT BROKE (SUBJECT OF THIS REPORT). ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAY-2019: WHEN SPEAKING WITH THE PHYSICIAN ABOUT THE EVENT, HE STATED THAT HE PULLED THE NEEDLE HANDLE BACK AND IT COMPLETELY DETACHED (SUBJECT OF THIS REPORT). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678724 ↗
• MalfunctionMar 18, 2019Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC CELIAC PLEXUS NEUROLYSIS PROCEDURE [OFF LABEL USAGE], THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. WHEN THE NEEDLE WAS RETRACTED BACK INTO THE SHEATH, THE HANDLE BROKE OFF AND IT [THE NEEDLE] CAME OFF THE SHAFT. THE DEVICE WAS REMOVED WITHOUT INCIDENT OR INTERVENTIONAL PROCEDURES. THE PROCEDURE WAS COMPLETE AT THIS POINT. THE DEVICE WAS RECEIVED FOR EVALUATION ON 27-FEB-2019 AND IT WAS CONFIRMED THE NEEDLE IS BROKEN AT THE HANDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429440 ↗
• MalfunctionNov 1, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE PHYSICIAN TRIED TO PUT THE NEEDLE DOWN THE ENDOSCOPE AND WAS HAVING TROUBLE PUSHING IT THROUGH. THE PHYSICIAN PULLED THE NEEDLE OUT AND IT WAS BENT ABOUT 6 OR 7 CMS, DISTAL TO THE TIP ITSELF. ANOTHER G31521-ECHO-3-22 WAS USED TO COMPLETED THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028709 ↗
• MalfunctionOct 9, 2018Material Twisted/Bent; Material Twisted/Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE NEEDLE WAS IN THE BOX WITH A BENT SHEATH. THEY TRIED TO PULL OUT THE STYLET. THAT WAS NOT POSSIBLE, SO THEY DID NOT USE THE NEEDLE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948951 ↗
• MalfunctionOct 4, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE (ECHO-3-22). THEY CHECKED THAT THE MASS LOCATION WAS THE BODY OF THE PANCREAS BEFORE THE PROCEDURE. THEY ADVANCED THE ECHO-3-22 TO THE MASS THROUGH THE ENDOSCOPE. HOWEVER, THE NEEDLE DID NOT FUNCTURE TO THE MASS IN EUS [SIC]. CONSEQUENTLY, THE NEEDLE WAS REMOVED OUT OF THE ENDOSCOPE. SO THEY USED ANOTHER ECHO-3-22. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12-SEPTEMBER-2018 AND DETERMINED TO HAVE A SIGNIFICANT BEND AT THE PATIENT END OF THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7934089 ↗
• MalfunctionAug 14, 2018Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE NEEDLE CANNOT BE RETRACTED INTO THE SHEATH DURING THE PROCEDURE (PUNCTURE). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781250 ↗
• MalfunctionMay 8, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE OPERATOR ADJUSTED THE SHEATH TO A SUITABLE LENGTH AND WAS READY TO ADVANCE, BUT IT FAILED AFTER SEVERAL TRIES ((B)(4)). THE DEVICE WAS EVALUATED ON 04/13/2018 AND IT WAS OBSERVED THAT THERE WAS A SIGNIFICANT BEND AT THE PATIENT END OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7494480 ↗
• MalfunctionMay 4, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE (ECHO-3-22). THEY PLACED THE DEVICE IN THE ENDOSCOPE, AND THEY TRIED TO ADVANCE THE NEEDLE. THE NEEDLE WOULD NOT ADVANCE. A NEW ECHO-3-22 WAS OPENED AND USED TO COMPLETE THE PROCEDURE (THERE WAS NO REPORTABLE INFORMATION AT THIS TIME). THE DEVICE WAS EVALUATED ON 04/10/2018 AND IT WAS OBSERVED THAT THE PATIENT END OF THE NEEDLE HAD A SIGNIFICANT BEND (SUBJECT OF THIS REPORT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486363 ↗
• MalfunctionMay 4, 2018Bent; Bent

  PRIOR TO AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE ECHO TIP NEEDLE WAS BENT.

  Patient problems: No Patient Involvement

  MAUDE report 7486276 ↗
• MalfunctionDec 26, 2017Bent; Bent

  IN PREPARATION FOR A FINE NEEDLE ASPIRATION (FNA) PROCEDURE, THE PHYSICIAN SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. BEFORE THE CASE, THE NURSE CHECKED THE PRODUCT FOR FUNCTIONALITY, AND FOUND THAT THE END OF THE SHEATH CURVED IRREGULARLY [SHEATH BENT]. THEY CHANGED TO ANOTHER NEEDLE [TO FINISH THE PROCEDURE]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12/04/2017, AND IT WAS FOUND TO HAVE A SEVERE BEND IN THE NEEDLE.

  Patient problems: No Patient Involvement

  MAUDE report 7146082 ↗
• MalfunctionNov 3, 2017Bent; Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. WHEN THE NEEDLE WAS REMOVED FROM THE PACKAGING, AN OBVIOUS KINK WAS SEEN IN THE SHEATH. THE REPRESENTATIVE WAS IN THE ROOM AND THE NEEDLE WAS HANDLED PROPERLY ON REMOVAL. THE FOLLOWING WAS RECEIVED ON 10/23/17: WHEN THE NEEDLE CAME OUT [OF THE] PACKAGING A VISIBLE KINK COULD BE SEEN. THE NURSE HANDLED THE NEEDLE CORRECTLY, AS A COOK EMPLOYEE WITNESSED. [THE PROCEDURE WAS] FINISHED WITH ANOTHER NEEDLE.

  Patient problems: No Patient Involvement

  MAUDE report 6999481 ↗
• MalfunctionOct 16, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. "THERE WAS A PROBLEM WITH THE NEEDLE. THE NEEDLE DID NOT GO OUT FROM THE CATHETER [EXTEND]. THEY TRIED FOUR (4) TIMES AND IT DID NOT WORK. THEY CHANGED THE NEEDLE FOR ANOTHER COOK NEEDLE, AND IT WORKED." THE DEVICE WAS EVALUATED ON 09/25/2017. THE NEEDLE WAS FOUND TO HAVE A SEVERE BEND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952508 ↗
• MalfunctionOct 6, 2017Bent; Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE CUSTOMER SAW THAT THE NEEDLE WAS KINKED IN TWO PLACES INSIDE THE PACKAGING. THE NEEDLE WAS USED. THE FOLLOWING ADDITIONAL INFORMATION ON 9/12/17: PRIOR TO USE, THE NEEDLE WAS KINKED IN THE PACKAGING IN TWO PLACES. OPEN AND UNUSED, THE PHYSICIAN DECIDED NOT TO USE THIS NEEDLE. RECEIVED 9/21/17: THE NEEDLE WAS KINKED IN THE PACKAGING, SEEN BY VISUALIZATION. THE NURSE DID NOT TOUCH NEEDLE.

  Patient problems: No Patient Involvement

  MAUDE report 6922019 ↗
• MalfunctionAug 2, 2017Bent; Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. WHEN THE USER OPENED THE PACKAGING, THE CATHETER WAS NOTED TO BE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760385 ↗
• MalfunctionJul 28, 2017Retraction Problem; Use of Device Problem; Retraction Problem; Use of Device Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE NEEDLE WAS PIERCED THROUGH THE SHEET [SHEATH]. THE LOT NUMBER COULD NOT BE CONFIRMED BY REPRESENTATIVE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 7/5/2017: [THE USER] TOOK THE COMPLETE ENDOSCOPE OUT BECAUSE THEY COULD NOT RETRACT THE NEEDLE AS IT WAS THROUGH THE WORKING CHANNEL. [THE USER] TOOK A NEW NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749823 ↗
• MalfunctionJul 27, 2017Bent; Bent

  DURING ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE PHYSICIAN STATED THAT THEY COULD NOT SEE THE NEEDLE IN THE LESION UNDER ULTRASOUND, SO ANOTHER NEEDLE WAS OPENED AND USED BUT THE SAME PROBLEM OCCURRED. THEY DECIDED TO CHANGE TO A COMPETITOR'S NEEDLE AND IT WORKED FINE. THE DEVICES WERE EVALUATED ON 07/05/2017. THEY WERE FOUND TO HAVE SEVERE BENDS IN THE DISTAL ENDS.(SUBJECT OF THIS REPORT. SEE ALSO MDR 1037905-2017-00495).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746965 ↗
• MalfunctionJul 27, 2017Bent; Bent

  DURING ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE PHYSICIAN STATED THAT THEY COULD NOT SEE THE NEEDLE IN THE LESION UNDER ULTRASOUND, SO ANOTHER NEEDLE WAS OPENED AND USED BUT THE SAME PROBLEM OCCURRED. THEY DECIDED TO CHANGE TO A COMPETITOR'S NEEDLE AND IT WORKED FINE. THE DEVICES WERE EVALUATED ON (B)(6) 2017. THEY WERE FOUND TO HAVE SEVERE BENDS IN THE DISTAL ENDS (SUBJECT OF THIS REPORT. SEE ALSO MDR 1037905-2017-00496).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746929 ↗
• MalfunctionJun 16, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THIS COMPLAINT OCCURRED AT SECOND PUNCTURE. THEY PUNCTURED WITH THE NEEDLE AT THE PANCREAS HEAD MASS UNDER ULTRASOUND. THEY COULD NOT PUNCTURE THE NEEDLE TO HEAD OF THE PANCREAS MASS UNDER EUS-GUIDED [THE SECOND PUNCTURE ATTEMPT] BECAUSE THEY TRIED TO PUT THE NEEDLE OUT [ADVANCE NEEDLE] BUT IT DID NOT COME OUT FROM NEEDLE SHEATH. THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/25/2017. THE NEEDLE HAD A SEVERE BEND IN THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648443 ↗
• MalfunctionMay 26, 2017Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE FIXATION KNOB OF THE SHEATH OF THE BIOPSY NEEDLE IS NOT WORKING PROPERLY. THE NEEDLE FELT LIKE IT WAS IMPOSSIBLE TO PULL IT BACK [UNABLE TO RETRACT NEEDLE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593802 ↗
• MalfunctionApr 14, 2017Bent; Bent

  THE FOLLOWING WAS REPORTED ON (B)(6) 2017: IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE NEEDLE WAS KINKED INSIDE THE PACKAGE. THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/07/2017. THE DEVICE WAS FOUND TO BE USED AND THE NEEDLE WAS BENT WHEN EXTENDED FROM THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494400 ↗
• MalfunctionApr 13, 2017Bent; Bent

  THE FOLLOWING WAS REPORTED ON 02/23/2017: IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. THE CUSTOMER COMPLAINED THAT THE SHEATH WAS KINKED AFTER REMOVAL FROM PACKAGING. ON 03/21/2017, THE DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A SEVERE BEND IN THE NEEDLE WHEN THE NEEDLE WAS EXTENDED. THERE WAS EVIDENCE THAT THE DEVICE HAD BEEN USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489609 ↗