Black Silicone G15144Recalls & 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
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002151444), received between Apr 5, 2017 and Oct 8, 2019 — classified as 1 death, 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
- Contamination /Decontamination Problem1
- Difficult to Remove1
- Material Fragmentation1
Patient problems
- Death1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 08OCT2019.
Patient problems: No Patient Involvement
MAUDE report 9167694 ↗DeathApr 5, 2017Break; Material Fragmentation; Difficult to Remove; Break; Material Fragmentation; Difficult to Remove
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A URETERAL STENT REMOVAL PROCEDURE. A (B)(6) MALE PATIENT WITH A SEPTIC STONE HAD A FILIFORM DOUBLE PIGTAIL URETERAL STENT IN PLACE FOR APPROXIMATELY THREE MONTHS. THE PHYSICIAN WAS REMOVING THE STENT IN ORDER TO REMOVE THE STONE. THE PATIENT HAD BEEN IN ICU FOR AN EXTENDED TIME. WHEN THE ATTENDING PHYSICIAN TRIED TO REMOVE THE STENT, IT WOULD BREAK OFF PIECE BY PIECE. THE COMPLETE REMOVAL OF THE STENT TOOK ABOUT ONE HOUR. THE PATIENT EVENTUALLY EXPIRED AND THE PHYSICIAN BELIEVES IF THE REMOVAL OF THE STENT HAD NOT TAKEN SO LONG THE PATIENT MAY HAVE SURVIVED. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Death
MAUDE report 6459889 ↗
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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