EchoTipRecalls & reported problems across all models
Cook Incorporated · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of EchoTip by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2016 and Sep 8, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “Bent” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EchoTip problems
Device problems
- Bent24
- Retraction Problem4
- Fracture3
- Improper or Incorrect Procedure or Method3
- Material Twisted/Bent3
- Break2
- Material Fragmentation2
- Difficult To Position1
Patient problems
- No Consequences Or Impact To Patient31
- No Patient Involvement4
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
EchoTip models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EchoTip G31521Biopsy needle35 reports
- EchoTip G25492Biopsy needle2 reports
- Echotip G16289Sampler, amniotic fluid (amniocentesis tray)1 report
Recent EchoTip adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 19, 2017Difficult To Position; Difficult To Position
THE USER FACILITY REPORTED DURING AN AMNIOCENTESIS PROCEDURE, THE COOK ECHO TIP AMNIOCENTESIS NEEDLE COULD NOT BE SEEN UNDER THE ULTRASOUND DURING THE PROCEDURE. ADDITIONAL INFORMATION THAT WAS RECEIVED WAS THE NEEDLE WAS MORE FLEXIBLE AND NOT VISIBLE. THERE WAS NO REPORT OF ANY ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7132627 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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