Sof-Flex G14840Recalls & reported problems
Cook Incorporated · Sof-Flex Double Pigtail Ureteral Stent Set · Class 2 · Implant
All models of Sof-Flex (14)
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 00827002148406), received between Apr 10, 2018 and Oct 7, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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
- Material Split, Cut or Torn2
- Material Separation1
- Tear, Rip or Hole in Device Packaging1
- Unraveled Material1
Patient problems
- No Consequences Or Impact To Patient3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 7, 2024Material Separation; Material Separation
AS REPORTED, A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET' WAS PLACED ON (B)(6) 2024 FOR A STENT RE-IMPLANT PROCEDURE AND FRACTURED AT THE PATIENTS HOME ON (B)(6) 2024. THE PATIENT REPORTED TO HAVE PAIN AND PASSED PART OF THE STENT AT HOME; THE PATIENT THEN RETURNED TO THE USER FACILITY FOR REMOVAL OF THE REMAINING STENT FRAGMENTS REMOVED FROM THE URETHRA AND BLADDER. ANOTHER STENT WAS NOT PLACED. THE STENT WAS NOT SET TO BE REMOVED FOR ANOTHER 2 WEE KS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY OTHER ADDITIONAL INTERVENTION OR EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient; Pain
MAUDE report 20385678 ↗MalfunctionOct 13, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625388 ↗MalfunctionMar 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
NO NEW PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9787731 ↗MalfunctionAug 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
PRIOR TO A STENT PLACEMENT, THE DISTAL TIP OF A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS FOUND TO BE SPLIT OPEN. ANOTHER SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS OPENED TO CARRY OUT THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8925202 ↗MalfunctionApr 10, 2018Tear, Rip or Hole in Device Packaging
THE COMPLAINANT REPORTED THAT THERE WAS A TEAR IN ONE FENESTRATED PIGTAIL END OF THE SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET. THERE WAS NO REPORTED HARM TO THE PATIENT AND NO DELAY IN THE CASE. IT IS NOT KNOWN IF THE DEVICE MADE PATIENT CONTACT, BUT NO SERIOUS INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7419669 ↗
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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