C-Flex G14897Recalls & reported problems
Cook Incorporated · C-Flex DP 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002148970), received between Sep 29, 2022 and Sep 29, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- Foreign Body In 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.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938352 ↗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 ↗InjurySep 29, 2022Break; Break
AS REPORTED, DURING REMOVAL OF A C-FLEX DOUBLE PIGTAIL URETERAL STENT, THE DEVICE SEPARATED. THE DEVICE WAS INDWELLING FOR TWO MONTHS. THE DEVICE WAS SEPARATED "WITH MINOR TRACTION" IN THE PATIENT'S URETER. AN ATTEMPT TO REMOVE THE SEPARATED SECTION OF THE STENT UNDER RADIOLOGY FAILED. THE DEVICE FRAGMENT WAS LEFT IN THE PATIENT'S RIGHT KIDNEY AND A NEPHROSCOPY PROCEDURE HAS BEEN SCHEDULED TO REMOVE THE DEVICE FRAGMENT. A VIDEO PROVIDED BY THE USER APPEARS TO SHOW AN ADDITIONAL DEVICE, REPORTEDLY FROM THE SAME LOT, BEING PULLED APART WITHIN THE USER¿S HANDS.
Patient problems: Foreign Body In Patient
MAUDE report 15505481 ↗
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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