C-Flex G15532Recalls & reported problems
Cook Incorporated · C-Flex Multi-Length Ureteral Stent Set · Class 2 · Implant
All models of C-Flex (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002155329), received between Apr 12, 2018 and Jun 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
- Material Integrity Problem1
- Material Too Rigid or Stiff1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 24, 2020Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED ON 03FEB2020: THE FRACTURE WAS DISCOVERED UPON INSPECTION OF THE STENT AS IT WAS REMOVED FROM THE PACKAGING AT THE SCRUB TABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9626691 ↗MalfunctionApr 12, 2018Break; Material Too Rigid or Stiff; Material Integrity Problem
IT WAS REPORTED THAT THE PHYSICIAN HAD AN ISSUE WITH THE C-FLEX MULTI-LENGTH URETERAL STENT THAT WAS USED. THE STENT APPEARED TO BE "VERY DRY AND RIGID," AND IT SNAPPED IN SEVERAL PLACES. THE STENT WAS ONLY PLACED OVER THE WIRE, AND THE PRODUCT PROBLEM WAS NOTICED BEFORE THE STENT WAS IMPLANTED. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7426417 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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