Flexi-TipRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 7 models of Flexi-Tip by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and Aug 18, 2026 — classified as 21 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Material Separation” (21 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 Flexi-Tip problems
Device problems
- Material Separation21
- Break16
- Fracture4
- Device Contaminated During Manufacture or Shipping3
- Peeled/Delaminated3
- Material Fragmentation2
- Contamination /Decontamination Problem1
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient17
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient11
- Foreign Body In Patient8
- Insufficient Information4
- No Code Available3
- No Information2
- Device Embedded In Tissue or Plaque1
Flexi-Tip models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flexi-Tip G14521CATHETER, UROLOGICAL37 reports
- Flexi-Tip G14809CATHETER, UROLOGICAL4 reports
- Flexi-Tip G15040CATHETER, UROLOGICAL4 reports
- Flexi-Tip G17323CATHETER, URETERAL, GASTRO-UROLOGY3 reports
- Flexi-Tip G14016CATHETER, UROLOGICAL2 reports
- Flexi-Tip G14015CATHETER, UROLOGICAL1 report
- Flexi-Tip G14808CATHETER, UROLOGICAL1 report
Recent Flexi-Tip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Break
It was reported to Cook that an Open-End Flexi-Tip Ureteral Catheter " disintegrated." The patient was undergoing a Retrograde Cystoscopy and Pyelography where the Open-End Flexi-Tip Ureteral Catheter was being used. A Ureteroscope from an unknown manufacturer was used. The scope was checked prior to use and no damage was noted. There was no resistance noted upon advancement of the catheter through the scope. It was noted that several fragments of the catheter broke off and required removal from the patient with endoscopic alligator forceps. The catheter was said to be used in the usual manner to complete the procedure. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303229 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A SECTION OF AN OPEN-END FLEXI-TIP URETERAL CATHETER SEPARATED OR WAS STRIPPED OFF. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23932955 ↗MalfunctionDec 15, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809891 ↗MalfunctionDec 12, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 06MAR2026. THE CATHETER DID GO THROUGH A SCOPE. THE SCOPE WAS CHECKED AND NO DAMAGED WAS OBSERVED. THE EVENT OCCURRED DURING A URETEROSCOPY PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23787007 ↗MalfunctionNov 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION WAS RECEIVED ON 13NOV2025 STATING THAT THE PROCEDURE WAS COMPLETED BY OPENING A NEW UNSPECIFIED DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486861 ↗MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834128 ↗MalfunctionAug 6, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THE OR USED AN OPEN-END FLEXI-TIP URETERAL CATHETER ON A PATIENT AND MENTIONED THAT UPON INSERTION, SOME OF THE URETERAL CATHETER SHAVED OFF IN THE PATIENT. THEY WERE TO RETRIEVE WHAT THEY COULD. IT IS UNKNOWN HOW THE PIECES WERE REMOVED OR IF ANY WERE RETAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 22730297 ↗MalfunctionApr 15, 2024Material Fragmentation; Material Fragmentation
AS REPORTED, DURING A STENT EXCHANGE, WHEN THE OPEN-END FLEXI-TIP URETERAL CATHETER WAS PULLED BACK THROUGH THE SCOPE, PIECES OF THE CATHETER "STRIPPED OFF. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19111455 ↗MalfunctionMar 14, 2024Material Separation; Material Separation
AS REPORTED, THE TIP OF A 'OPEN-END FLEXI-TIP URETERAL CATHETER' FELL OFF IN THE PATIENTS BLADDER DURING A PROCEDURE. THE DEVICE WAS INSERTED INTO THE PATIENTS BLADDER VIA THE URETER. UPON REACHING THE BLADDER, TWO PIECES OF THE TIP SEPARATED FROM THE DEVICE IN THE PATIENTS BLADDER. THE DEVICE WAS REMOVED FROM THE RIGID CYSTOSCOPE PORT AND THE TWO FRAGMENTS WERE REMOVED USING A CYSTOSCOPE AND CYSTOSCOPY GRASPER. UPON REMOVAL, THE EDGES APPEARED CUT AND THE SCOPE HAD SHARP EDGES. THE PROCEDURE WAS COMPLETED USING A NEW 'YELLOW CATHETER'. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909149 ↗MalfunctionSep 28, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PORTION OF AN OPEN-END FLEXI-TIP URETERAL CATHETER SEPARATED DURING USE. DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND INTRAOPERATIVE CHOLANGIOGRAM PROCEDURE, THE USER NOTICED ON THE LAPAROSCOPY MONITOR SCREEN "SOME LOOSE PLASTIC" VISIBLE INSIDE THE ABDOMEN OF THE PATIENT. THE UNKNOWN OBJECT WAS REMOVED WITH CHOLANGIOGRAM FORCEPS AND WAS DETERMINED AFTERWARDS TO BE A PORTION OF THE URETERAL CATHETER THAT HAD BEEN "SHAVED" OFF. THE ITEM WAS COMPLETELY REMOVED; NO PORTION OF THE DEVICE WAS LEFT INSIDE THE ABDOMEN. RESISTANCE UPON ADVANCEMENT OR REMOVAL OF THE CATHETER WAS DENIED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17836478 ↗InjuryDec 16, 2022Break; Break
AS REPORTED, AN OPEN-END FLEXI-TIP URETERAL CATHETER SEPARATED IN THE URETER WHEN DURING A RETROGRADE PYLEOGRAM PROCEDURE. THE SEPARATION WAS NOTICED AFTER THE STENT WAS PLACED. THE REMAINING PORTION OF THE FLEXI-TIP WAS RETRIEVED FROM THE KIDNEY WITH A STONE EXTRACTOR. THE PROCEDURE WAS COMPLETED AS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15997250 ↗InjuryJul 18, 2022Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN OPEN-END FLEXI-TIP URETERAL CATHETER BROKE DURING USE. A URETEROSCOPY HAD TO BE PERFORMED TO RETRIEVE THE BROKEN PIECE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15043386 ↗InjuryJul 8, 2022Break; Break
AS REPORTED, THE TIP OF A OPEN-END FLEXI-TIP URETERAL CATHETER BROKE OFF INSIDE OF THE PATIENT'S BODY. THE TIP WAS RETRIEVED INTRA-OPERATIVELY. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 14955775 ↗InjuryJun 23, 2022Break; Break
AS REPORTED, DURING A CYSTOLITHOLAPAXY, THE DISTAL END OF AN OPEN-END FLEXI-TIP URETERAL CATHETER SEPARATED WHILE IN THE PATIENT. THE SEPARATION WAS DISCOVERED BY THE SURGEON UNDER DIRECT VISUALIZATION. THE SEPARATED SEGMENT OF THE DEVICE WAS "RETRIEVED" FROM THE PATIENT BY UNKNOWN MEANS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 14786682 ↗InjuryMar 31, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, AN OPEN-END FLEXI-TIP URETERAL CATHETER DELAMINATED WHEN COMING INTO CONTACT WITH A CYSTOSCOPE. "DEBRIS" WAS REMOVED FROM THE PATIENT BY UNKNOWN MEANS. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE, AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAVE BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 13964289 ↗
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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