Sof-Flex G14898Recalls & reported problems
Cook Incorporated · Sof-Flex Double Pigtail Ureteral Stent Set · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002148987), received between Feb 8, 2019 and Sep 30, 2024 — classified as 1 injury, 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
- Material Separation1
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2024Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device
IT WAS REPORTED THAT A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' WAS PLACED ON (B)(6) 2024 FOR TREATMENT OF A PELVIC TUMOR AND HYDRONEPHROSIS. THE PATIENT WAS DISCHARGED HOME BUT RETURNED ON (B)(6) 2024 DUE TO THE STENT PROTRUDING FROM URETHRAL MEATUS. THE PATIENT RETURNED TO THE OPERATING ROOM WHERE IT WAS NOTED THAT THE DEVICE HAD SEPARATED; THE SURGEON USED A URETEROSCOPE TO CHECK FOR ANY REMAINING STENT FRAGMENTS IN THE URETHRA AND KIDNEY. IT WAS REPORTED THAT THE REMAINING PIECES OF THE STENT WERE REMOVED. A REPLACEMENT STENT WAS PLACED AND THE PATIENT WAS HOSPITALIZED FOR AN ADDITIONAL DAY. THE DEVICE DID NOT PERFORATE ANY PART OF THE PATIENT'S ANATOMY.
Patient problems: Foreign Body In Patient
MAUDE report 20334071 ↗MalfunctionFeb 8, 2019Material Separation; Material Separation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8321779 ↗
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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