Cook G46440Recalls & reported problems
Cook Incorporated · Black Silicone Filiform Double Pigtail Ureteral Stent Set · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002464407), received between Mar 22, 2023 and Sep 15, 2026 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Break
As reported, prior to an ureteroscopic lithotripsy (URSL) procedure, the user found " one side of the tip was broken" on a BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT upon opening the package. The user replaced the device with a new BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT to complete the procedure without difficulties. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A customer provided photo shows a section of the distal coil separated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777250 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT THE ¿BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT¿ BROKE MID-SECTION DURING ATTEMPTED REMOVAL. THE PATIENT HAD BILATERAL STENT PLACEMENT DURING A URETEROSCOPY ON AN UNKNOWN DATE. DURING ATTEMPTED REMOVAL ON (B)(6) 2024, THE LEFT STENT BROKE IN THE MIDDLE OF THE STENT. THE RETAINED PORTION OF THE STENT WAS SUCCESSFULLY RETRIEVED USING AN AN EXTRACTOR VIA THE URETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20546569 ↗MalfunctionSep 5, 2024
ELDERLY MALE WITH HISTORY OF ACUTE ON CHRONIC KIDNEY DISEASE. PROCEDURE: CYSTOSCOPY, RETROGRADE, PYELOGRAM, URETEROSCOPY AND LEFT JJ STENT PLACEMENT. AFTER PLACING A URETERAL STENT, IT WAS OBSERVED THAT THE METAL TIP WAS OFF THE PUSHER AND THE GLIDEWIRE WAS FRAYED. METAL TIP WAS OBSERVED ON THE SET-UP TRAY SO THE TIP WAS NOT IN THE GLIDEWIRE WHEN USED ON THE PATIENT. NO KNOWN HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20144625 ↗MalfunctionMar 30, 2023Difficult to Advance; Difficult to Advance
AS REPORTED, THE BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENTS DO NOT SLIDE EASILY OVER ANOTHER MANUFACTURER'S GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643428 ↗MalfunctionMar 22, 2023Break; 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 16592815 ↗
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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