Universa G49937Recalls & reported problems
Cook Incorporated · Universa Soft Ureteral Stent Set with Hydrophilic Coating · Class 2 · Implant
All models of Universa (82)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002499379), received between Sep 14, 2017 and May 27, 2025 — classified as 3 malfunctions.
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. 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
- Break1
- Material Split, Cut or Torn1
- Split1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED A STENT FROM A UNIVERSA SOFT URETERAL STENT SET WAS FOUND BROKEN AT THE TIP AROUND 1 CM WITH THE TETHERS STILL ON IT, PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS NOT INSERTED INTO THE PATIENT AND THE ISSUE WAS DISCOVERED WHEN THE USER WAS PREPARING IT FOR IMPLANT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. 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 22089916 ↗MalfunctionJul 29, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 29JUL2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8836290 ↗MalfunctionSep 14, 2017Split; Split
THE USER FACILITY REPORTED WHILE TRYING TO USE THE UNIVERSA SOFT URETERAL STENT, A SPLIT DISTAL END CAUSED IT TO NOT BE ABLE TO BE USED. AS REPORTED, THERE WAS NO HARM TO THE PATIENT. ADDITIONAL PATIENT, DEVICE AND EVENT INFORMATION HAS BEEN REQUESTED BUT REPLY HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6864933 ↗
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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