Black Silicone G15124Recalls & reported problems
Cook Incorporated · Black Silicone Filiform Dbl 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002151246), received between Apr 12, 2018 and Apr 6, 2026 — classified as 4 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT PRIOR TO A URETER PROCEDURE, UPON OPENING THE PACKAGE, A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET'S STENT WAS FOUND BROKEN NEAR THE END OF THE PIGTAIL. THE STENT WAS REPLACED WITH A NEW SAME-LIKE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794096 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THE STENT OF A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS FRACTURED PRIOR TO AN UNKNOWN PROCEDURE IN THE URETER. UPON OPENING THE PACKAGING, THE PIGTAIL END OF THE UPPER SEGMENT OF THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED BY USING A REPLACEMENT STENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215590 ↗MalfunctionSep 5, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978375 ↗MalfunctionApr 12, 2018Torn Material
IT WAS REPORTED THAT THE DISTAL END OF THE URETERAL STENT WAS TORN. IT WAS FURTHER NOTED THAT THE PROXIMAL COIL OF THE STENT WAS TORN STARTING AT THE LAST SIDEPORT AND CONTINUING THROUGH THE TIP. THE CUSTOMER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE AND NO PATIENT HARMS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7425841 ↗
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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