Cook G46438Recalls & 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 00827002464384), received between Mar 30, 2023 and Mar 10, 2025 — 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 Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT THE 'BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT' BROKE DURING REMOVAL. AS REPORTED, THREE STENTS FROM THE SAME LOT BROKE DURING REMOVAL OVER A SPAN OF TWO DAYS. REPORTEDLY, NO PATIENTS WERE HARMED. IT WAS NOTED THAT SURGEONS HAVE BEEN USING 6F STENTS, LARGER THAN 5F STENTS THEY ARE BEING USED TO. IT IS BELIEVED THAT THE ISSUE MAY BE OCCURRING WHEN ATTEMPTING TO REMOVE THE 6F STENT THROUGH A SHEATH INTENDED FOR USE WITH 5F STENTS. AS REPORTED, NO SECTION OF DEVICE REMAINS INSIDE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information
MAUDE report 21558968 ↗MalfunctionJan 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. THE RIGHT STENT BROKE DISTAL TO THE URETERAL ORIFICE AND WAS REMOVED WITH A CYSTOSCOPE AND STENT GRASPER DURING THE SAME PROCEDURE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21190959 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THE BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT BOTTOM CURL OF THE STENT BROKE OFF AS IT WAS BEING ADVANCED OVER THE WIRE BEFORE THAT PART OF THE DEVICE ENTERED THE PATIENT DURING URETEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LIKE-DEVICE. 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 20675486 ↗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 16648016 ↗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 16643477 ↗
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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