Black Silicone G15120Recalls & reported problems
Cook Incorporated · Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating · Class 2 · Implant
All models of Black Silicone (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002151208), received between Apr 12, 2018 and Apr 30, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2018Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED THAT THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BROKE AT THE DISTAL END AS THE DOCTOR WAS TRYING TO PULL IT OUT DURING A LEFT URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT REMOVAL PROCEDURE. THE STENT WAS ENCRUSTED AT THE PROXIMAL END AND A STONE HAD FORMED. DUE TO THE APPLIED PRESSURE AND THE SIZE OF THE STONE, THE DOCTOR WAS UNABLE TO PULL THE STENT OUT AND THEREFORE IT WAS UNABLE TO WITHSTAND THE PRESSURE AND SNAPPED. THE DOCTOR WAS ABLE TO FINISH THE CASE AND NO ADDITIONAL PROCEDURES WERE REQUIRED. THE PATIENT WAS SAFE AND ANOTHER STENT WAS PLACED AFTER THE STONE BURDEN WAS REMOVED. THE PROXIMAL END OF THE STENT WAS REMOVED FROM THE RENAL PELVIS WITH THREE PRONGED GRASPER THAT FIT THROUGH A URETEROSCOPE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7473065 ↗MalfunctionApr 12, 2018Detachment Of Device Component
THE COMPLAINANT REPORTED THAT THE PIGTAIL TIP OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT WAS DETACHED WHEN THE WIRE GUIDE WENT THROUGH. THE LENGTH OF THE DETACHED STENT WAS ABOUT 1CM (CENTIMETER). THE COMPLAINT DEVICE WAS REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT, AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7426981 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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