Cook G46443Recalls & reported problems
Cook Incorporated · Black Silicone Filiform Double Pigtail Ureteral Stent Set · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002464438), received between May 6, 2025 and May 6, 2025 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THERE HAVE BEEN ISSUES WITH STENT BREAKAGE FOR THE PAST FEW MONTHS/WEEKS REGARDING THE BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT. THE FACILITY IS REQUIRED TO REMOVE THE DOUBLE J STENTS A FEW WEEKS POST-TRANSPLANT SURGERY AND HAVE HAD TO MODIFY THEIR REMOVAL TECHNIQUES RECENTLY TO MINIMIZE THIS OCCURRENCE. THE PHYSICIANS PERFORMING MOST OF THE REMOVALS HAVE BEEN RESIDENTS. RECENTLY, THE INITIAL REPORTER REMOVED A STENT WITHOUT ANY PROBLEMS. AFTER REMOVAL IT WAS FOUND THE STENT WAS VERY RESISTANT TO BREAKAGE, SUGGESTING THAT THE ISSUE MIGHT BE RELATED TO THE RESIDENTS' INEXPERIENCE. HOWEVER, UPON REMOVAL OF ANOTHER STENT WITHOUT ISSUE, THIS STENT WAS FOUND TO BE VERY FRAGILE AND BROKE APART WITH MINIMAL EFFORT. THERE HAS BEEN NO INFORMATION REGARDING PATIENT ADVERSE EFFECTS. IT HAS BEEN REPORTED NO ADDITIONAL CASE SPECIFIC INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21968687 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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