Universa G49974Recalls & reported problems
Cook Incorporated · Universa Soft Ureteral Stent and Positioner 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002499741), received between Oct 4, 2017 and Aug 3, 2020 — classified as 1 injury, 3 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.
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Biocompatibility1
- Material Discolored1
Patient problems
- No Consequences Or Impact To Patient3
- Calcium Deposits/Calcification1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10359096 ↗MalfunctionJul 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8833068 ↗InjuryOct 9, 2018Biocompatibility; Biocompatibility
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: Calcium Deposits/Calcification; No Code Available
MAUDE report 7947799 ↗MalfunctionOct 4, 2017Material Discolored; Material Discolored
DISCOLORATION OF THE UNIVERSA SOFT URETERAL STENT SET WAS OBSERVED PRIOR TO INSERTION IN THE PATIENT. THIS DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS ISSUE. NO ADVERSE CONSEQUENCES OR ADVERSE EFFECTS WERE CAUSED TO THE PATIENT .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6913278 ↗
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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