C-FlexRecalls & 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
- 31
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 7 models of C-Flex by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2016 and Sep 29, 2026 — classified as 11 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Break” (15 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 C-Flex problems
Device problems
- Break15
- Material Separation7
- Flaked4
- Peeled/Delaminated3
- Unraveled Material2
- Device Contamination with Chemical or Other Material1
- Device Damaged Prior to Use1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Foreign Body In Patient8
- No Consequences Or Impact To Patient5
- Insufficient Information3
- No Patient Involvement3
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
C-Flex models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- C-Flex G14834STENT, URETERAL9 reports
- C-Flex G14637STENT, URETERAL7 reports
- C-Flex G17306STENT, URETERAL5 reports
- C-Flex G14787STENT, URETERAL3 reports
- C-Flex G14897STENT, URETERAL3 reports
- C-Flex G15532STENT, URETERAL3 reports
- C-Flex G14700STENT, URETERAL1 report
Recent C-Flex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938352 ↗InjurySep 16, 2026Break
It was reported that the stent from a C-Flex Double Pigtail Ureteral Stent Set separated.During an endoscopy procedure on (b)(6) 2026 to remove the stent that had been placed on (b)(6) 2026, the surgeon found black fragments in the patient's bladder that appeared to originate from the stent. The surgeon proceeded to remove a nearly complete ring plus a few fragments. Examination of the stent found the appearance to be unremarkable except for the two missing black bands, one of which is normally present at each end of the stent. No complications occurred during the stone removal procedure; however, there was a risk of stone formation.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: Foreign Body In Patient
MAUDE report 50793120 ↗InjuryMar 24, 2026Flaked
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24674729 ↗InjuryMar 24, 2026Flaked
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24674654 ↗MalfunctionMar 23, 2026Break; Flaked
IT WAS REPORTED THE C-FLEX DOUBLE PIGTAIL URETERAL STENT SET¿S STENT BROKE OFF BLACK PIECES INTO THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE SEPARATED DEVICE PORTION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664122 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED, DURING A URETEROSCOPY, WHEN A STENT FROM A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET WAS INSERTED, THE SURGEON NOTICED ONE OF THE PIGTAIL ENDS WAS CRACKED AND SOME SMALL FRAGMENTS OF THE OUTER COATING FLAKED OFF. THE STENT WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER ONE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523291 ↗InjuryJan 29, 2026Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 24210402 ↗InjuryJan 21, 2026Break
AS REPORTED, DURING A CYSTOSCOPY PROCEDURE, THE TIP OF THE 4.0 FR/70 CM STENT INCLUDED IN THE 'C-FLEX DOUBLE PIGTAIL URETERAL STENT SET' BROKE INSIDE OF PATIENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 24131818 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED DURING A STENT INSERTION PROCEDURE, WHEN THE SURGEON ATTEMPTED TO INSERT THE C-FLEX MULTI-LENGTH URETERAL STENT SET, SHE NOTED THAT IT FELT "DIFFERENT" TO NORMAL. THE STENT WAS FOUND TO BE BRITTLE AND BROKE EASILY IN HER FINGERS. ANOTHER STENT WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298312 ↗MalfunctionJun 16, 2025Break; Break
IT WAS REPORTED DURING A ROBOTIC PYELOPLASTY PROCEDURE, DURING URETERAL STENT PLACEMENT, THE STENT OF A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET BROKE INTO PIECES WHEN THE STENT WAS BEING WETTED WITH SALINE. THE PROCEDURE WAS CONTINUED WITHOUT STENT PLACEMENT. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212657 ↗MalfunctionMay 15, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED 26MAY2023: THE PROCEDURE STARTED WITH A URETERAL STONE REMOVAL WHILE DOING A CYSTOSCOPY. DURING THE PROCEDURE, THE DOCTOR NOTICED THE STENT MIGRATED TO THE URETER. A URETEROSCOPY PROCEDURE WAS COMPLETED TO FIND THE REST OF THE STENT. THE STENT WAS REMOVED AND NO LONGER IN THE PATIENT. THE IMPLANT DATE OF THE STENT WAS ON (B)(6) 2022 AND THE EXPLANT DATE OF THE STENT WAS ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16934917 ↗MalfunctionJan 12, 2023Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material
TWO COMPLAINT DEVICES WERE RETURNED TO COOK FOR INVESTIGATION, HOWEVER, COOK IS UNABLE TO DETERMINE WHICH WIRE IS FOR WHICH COMPLAINT DUE TO THEM BEING RETURNED IN THE SAME PACKAGE. THE FIRST WIRE (MANUFACTURER REPORT # 1820334-2023-00025) WAS RETURNED UNRAVELED. THE SECOND WIRE (CAPTURED UNDER THIS COMPLAINT) WAS RETURNED UNRAVELED AND SEPARATED.
Patient problems: Insufficient Information
MAUDE report 16154582 ↗MalfunctionJan 12, 2023Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material
TWO COMPLAINT DEVICES WERE RETURNED TO COOK FOR INVESTIGATION, HOWEVER, COOK IS UNABLE TO DETERMINE WHICH WIRE IS FOR WHICH COMPLAINT DUE TO THEM BEING RETURNED IN THE SAME PACKAGE. THE FIRST WIRE (CAPTURED UNDER THIS COMPLAINT) WAS RETURNED UNRAVELED. THE SECOND WIRE (CAPTURED UNDER MANUFACTURER REPORT # 1820334-2023-00026) WAS RETURNED UNRAVELED AND SEPARATED.
Patient problems: Insufficient Information
MAUDE report 16154536 ↗InjuryOct 11, 2022Break; Break
AS REPORTED, A C-FLEX DOUBLE PIGTAIL URETERAL STENT SEPARATED WITHIN A PATIENT'S URETER. SEGMENTS OF THE DEVICE REMAINED IN THE PATIENT'S KIDNEYS. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15580583 ↗MalfunctionOct 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, ONE END OF A C-FLEX MULTI-LENGTH URETERAL STENT WAS OBSERVED TO BE SPLIT WHEN OPENING THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW STENT WAS USED TO CONTINUE THE PROCEDURE WITHOUT ISSUE. 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 15549355 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page