Cook G46439Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002464391), received between Mar 30, 2023 and Dec 19, 2025 — classified as 1 injury, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Difficult to Advance2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED, DURING RETROGRADE INTRARENAL SURGERY (RIRS), THE WIRE GUIDE WOULD NOT ADVANCE THROUGH A BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT WITHOUT DIFFICULTY. 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 23849570 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) WITH STENT REPLACEMENT. DURING THE REMOVAL OF THE BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT, THE SURGEON FOUND THAT ONE SIDE OF THE TIP WAS BROKEN. THE STENT HAD BEEN PLACED LESS THAN TWO MONTHS AGO. ANOTHER DEVICE AND FORCEPS CLAMP WAS USED TO REMOVE THE BROKEN STENT AND ANOTHER SAME STENT WAS PLACED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTIES. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689420 ↗InjuryJan 20, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED 20JAN2025: THE STENT WAS INITIALLY PLACED FOR TREATMENT OF MALIGNANT COMPRESSION OF THE URETERS SECONDARY TO METASTATIC PROSTATE CANCER. THE STENT WAS BEING REMOVED FOR A ROUTINE STENT EXCHANGE. THE STENT WAS NOT BEING MONITORED BUT WAS EXCHANGED AT 8 MONTHS. ON THE LEFT SIDE, THE UPPER STENT FRAGMENT HAD TO BE REMOVED WITH URETEROSCOPY, AND A STONE BASKET WAS NEEDED TO GRASP THE STENT DURING THE SAME PROCEDURE. THE PATIENT WILL RETURN TO THE FACILITY WHEN THE FACILITY HAS ACCESS TO A LASER FOR REMOVAL OF THE ENCRUSTED, LEFT, UPPER, STENT FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 21190984 ↗MalfunctionJul 5, 2024Break; Material Separation; Break; Material Separation
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 19681289 ↗MalfunctionMar 30, 2023Difficult to Advance; Difficult to Advance
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 16643312 ↗
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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