Flexi-Tip G14521Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002145214), received between Mar 8, 2016 and Aug 18, 2026 — classified as 14 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 most recent of 37 reports, 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 ↗
• 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 ↗
• InjuryApr 20, 2021Material Separation; Material Separation

  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 11695163 ↗
• InjuryFeb 24, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11373276 ↗
• MalfunctionDec 29, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; No Information

  MAUDE report 11090472 ↗
• MalfunctionDec 18, 2020Material Separation; Material Separation

  IT WAS REPORTED, THE FLEXI-TIP OF AN OPEN-END FLEXI-TIP URETERAL CATHETER CAME OFF OF THE REST OF THE CATHETER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. 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: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Information

  MAUDE report 11037761 ↗
• InjuryAug 26, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 27AUG2020: IT WAS REPORTED, A CYSTOSCOPY W/ BILATERAL RETROGRADE PYELOGRAM PROCEDURE WAS BEING PERFORMED ON A PEDIATRIC PATIENT (PATIENT AGE NOT PROVIDED). THE OPEN-END FLEXI-TIP URETERAL CATHETER WAS INDWELLING 5 MINUTES, ONLY DURING THE PROCEDURE. THE PROCEDURE WAS EXTENDED LESS THAN 5 MINUTES TO RETRIEVE THE SEPARATED PIECE. A FLEXIBLE GRASPER WAS USED TO RETRIEVE BROKEN CATHETER TIP. A .035 WIRE WAS USED TO PLACE THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10455218 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934337 ↗
• MalfunctionFeb 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT UNDER LOCAL ANESTHESIA, A OPEN-END FLEXI-TIP URETERAL CATHETER WAS IN USE WHEN ITS TIP DETACHED WITHIN THE PATIENT'S BLADDER. THE TIP OF THE CATHETER WAS REMOVED WITH SEMI-RIGID GRASPERS DURING THE CASE. NO PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675851 ↗
• MalfunctionJan 8, 2020Break; Break

  NO ADDITIONAL PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564123 ↗
• InjuryOct 2, 2019Fracture; Fracture

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 02OCT2019.

  Patient problems: No Code Available

  MAUDE report 9146885 ↗
• MalfunctionJul 3, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHILE PREPARING FOR AN UNSPECIFIED PROCEDURE USING AN OPEN-END FLEXI-TIP URETERAL CATHETER, THE CUSTOMER FOUND A HAIR LIKE FIBER INSIDE THE SEALED PACKAGE. THIS DEVICE WAS NOT USED. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 8759795 ↗
• MalfunctionMar 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THE OPEN END FLEXI TIP URETERAL CATHETER SHATTERED DURING A CASE. AN ELLICK EVALUATOR WAS USED TO EVACUATE THE PIECES FROM THE BLADDER. A NEW CATHETER TO BE USED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. ADDITIONAL DETAILS HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413193 ↗
• MalfunctionJan 22, 2019Material Separation; Material Separation

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267805 ↗
• MalfunctionNov 29, 2018Material Separation; Material Separation

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115599 ↗