C-Flex G14787Recalls & reported problems
Cook Incorporated · C-Flex Double Pigtail 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002147874), received between Feb 6, 2017 and Oct 11, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation2
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJul 30, 2019Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 8840874 ↗InjuryFeb 6, 2017Material Separation; Material Separation
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE USING AN C-FLEX DOUBLE PIGTAIL URETERAL STENT SET. THE ATTENDING PHYSICIAN INDICATED THAT WHILE INSERTING THE STENT A PIECE OF PLASTIC SHEARED OFF THE SHEATH. NO UNINTENDED SECTIONS OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY NOR DID THE PATIENT EXPERIENCE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6303213 ↗
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.
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