Cook G14274Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00827002142749), received between May 1, 2017 and Sep 16, 2026 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793686 ↗
• MalfunctionMay 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED, THERE WAS A HAIR IN THE PACKAGE OF AN OPEN-END URETERAL CATHETER. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE URETEROSCOPY. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035896 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED DURING AN URETEROSCOPY, THE USER INSERTED THE OPEN-END URETERAL CATHETER INTO THE URETEROSCOPE CHANNEL, AND IT BROKE IN HALF. A SECOND URETERAL CATHETER WAS USED WITHOUT ISSUE TO CONTINUE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900743 ↗
• MalfunctionNov 25, 2024Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN OPEN-END URETERAL CATHETER "BROKE." NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. 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

  MAUDE report 20770764 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THE OPEN-END URETERAL CATHETER WAS CUT IN TWO PIECES PRIOR TO A RETROGRADE PYELOGRAM (RPG) AND STENTING PROCEDURE. THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE ISSUED WAS FOUND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582281 ↗
• MalfunctionJun 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE OPEN-END URETERAL CATHETER'S STERILIZED BAG CONTAINED FOREIGN MATTER. THE FOREIGN MATTER WAS FOUND DURING CHECK IN WHEN THE HOSPITAL RECEIVED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610508 ↗
• MalfunctionAug 7, 2023Device 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 17470842 ↗
• MalfunctionJul 19, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED ON 31JUL2023 STATING THE EVENT WAS DISCOVERED "IN THE ROOM" PRIOR TO THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING THE SAME TYPE AND SIZE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352687 ↗
• InjuryApr 21, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 03MAY2023: AS REPORTED, AN OPEN-END URETERAL CATHETER SPLIT INTO 3 PIECES DURING AN UNSPECIFIED PROCEDURE. THE URETERIC CATHETER WAS INSERTED OVER THE GUIDEWIRE AS PER NORMAL, WHEN THE SURGEON WAS TRYING TO INSERT FURTHER INTO THE URETER THE CATHETER BROKE INTO 3 PIECES. THE PROCEDURE WAS PROLONGED DUE TO THE SMALLER PIECE OF THE CATHETER WAS HARD TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789412 ↗
• InjuryMar 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, AND INSERTION OF LEFT URETERIC STENT PROCEDURE, THE OPEN-END URETERAL CATHETER STENT SNAPPED IN HALF WHEN IT WAS BEING RETRACTED. THE DEVICE WAS INSERTED THROUGH THE SCOPE; ONCE INSIDE THE BLADDER THE DEVICE SNAPPED AND WAS BROKEN INTO TWO PARTS. THE DEVICE SEGMENTS WERE MANUALLY RETRIEVED THROUGH X-RAY GUIDANCE. 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 16592568 ↗
• InjuryJul 26, 2022Break; Break

  AS REPORTED, DURING A CYSTOSTOMY, AN APPROXIMATELY ONE INCH SEGMENT OF AN OPEN-END URETERAL CATHETER SEPARATED WITHIN THE PATIENT'S BLADDER. THE CATHETER WAS REMOVED FROM THE PATIENT, AND THE SEPARATED SEGMENT WAS RETRIEVED FROM THE BLADDER BY UNKNOWN MEANS. NO SEGMENT OF THE DEVICE WAS LEFT IN THE PATIENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15102433 ↗
• MalfunctionJul 5, 2022Break; Break

  AS REPORTED, A OPEN-END URETERAL CATHETER BROKE WHILE INSIDE A SHEATH. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14915345 ↗
• MalfunctionJul 8, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED ON 23JUL2021: THE PROCEDURES BEING COMPLETED WERE A CYSTOSCOPY WITH RIGHT URETEROSCOPY, HOLMIUM LASER LITHOTRIPSY, RETROGRADE PYELOGRAM, AND URETERAL STENT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140178 ↗
• MalfunctionFeb 11, 2021Break; 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; No Consequences Or Impact To Patient

  MAUDE report 11318599 ↗
• InjuryDec 1, 2020Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

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

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10926888 ↗
• MalfunctionJun 5, 2020Nonstandard Device; Contamination /Decontamination Problem; Nonstandard Device; Contamination /Decontamination Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123889 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785211 ↗
• MalfunctionJan 17, 2020Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602492 ↗
• MalfunctionAug 19, 2019Fracture; Fracture

  A USER FACILITY SUS REPORT#: MW5088794 WAS RECEIVED ON 26AUG2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907273 ↗
• MalfunctionJul 23, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO BE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8816789 ↗
• MalfunctionJan 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE A CLINICIAN WAS PERFORMING AN UNSPECIFIED PROCEDURE USING A COOK OPEN-END URETERAL CATHETER, THE PRODUCT BROKE IN THE BLADDER. ACCORDING TO THE CLINICIAN ALL PARTS WERE RETRIEVED. THE PRODUCT IS NO LONGER AVAILABLE FOR EVALUATION, BUT THE PACKAGING WAS KEPT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PROCEDURE, PATIENT INFORMATION INCLUDING OUTCOME, AND CONCOMITANT DEVICES. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8223544 ↗
• MalfunctionSep 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THE OPEN-END URETERAL CATHETER WAS BEING INSERTED OVER THE WIRE THROUGH THE SCOPE, AND DID NOT FEEL "NATURAL" TO THE PHYSICIAN. THE PHYSICIAN TOOK THE SCOPE OUT AND FOUND THE CATHETER HAD SNAPPED OFF CLEAN. THE PATIENT¿S ANATOMY WAS NOT SCARRED, CALCIFIED, OR TORTUOUS. THE PHYSICIAN RETRIEVED THE BROKEN CATHETER WITH HIS HAND. A NEW CATHETER HAD TO BE INSERTED TO COMPLETE THE PROCEDURE. INSERTION OF THE NEW CATHETER ADDED AN ADDITIONAL TWO MINUTES TO THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT(S) DUE TO THIS EVENT. THE PATIENTS OUTCOME POST PROCEDURE WAS "OK".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868508 ↗
• MalfunctionApr 12, 2018Crack

  THE COMPLAINANT REPORTED THAT THE END OF THE OPEN-END URETERAL CATHETER CRACKED WHERE THE WIRE WOULD COME OUT. IT WAS FURTHER NOTED THAT THE CATHETER WAS SEVERED IN TWO LOCATIONS, 25.6 CM (CENTIMETERS) AND 26.3 CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427418 ↗
• MalfunctionApr 9, 2018Break; Break

  IT WAS REPORTED THAT THE OPEN-END URETERAL CATHETER WAS DRY AND KINKED AND THEN BROKE INTO TWO PIECES WHEN BEING INSERTED INTO THE PATIENT DURING A URETERAL CATHETER PLACEMENT PROCEDURE. ONE PIECE STAYED INSIDE AND HAD TO BE REMOVED. A SECOND CATHETER WAS THEN USED BUT THE SAME INCIDENT OCCURRED. THE SECOND CATHETER THAT BROKE WAS FROM THE SAME LOT NUMBER. BOTH CATHETERS BROKE INTO TWO PIECES AND WERE FULLY REMOVED FROM THE PATIENT. AS REPORTED, NO SECTION OF THE DEVICE WAS RETAINED BY THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406163 ↗
• MalfunctionMar 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED AN EYELASH WAS OBSERVED INSIDE THE STERILE PACKAGE OF A URETERAL CATHETER PRIOR TO OPENING THE POUCH. THIS PACKAGING ANOMALY WAS DETECTED PRIOR TO USE; THEREFORE, NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7371771 ↗