Universa G23313Recalls & reported problems
Cook Incorporated · Universa Firm Ureteral Stent and Positioner With Hydrophilic Coating and Monofilament Tether · Class 2 · Implant
All models of Universa (82)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002233130), received between Jan 18, 2017 and Jan 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Difficult to Remove1
- Kinked1
Patient problems
- Awareness During Anesthesia1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2017Kinked; Difficult to Remove; Kinked; Difficult to Remove
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH STENT PLACEMENT FOR WELL DRAINAGE. DURING AN IMPLANT REMOVAL A FEW WEEKS POST IMPLANT, THE STENT WAS NOT ABLE TO COME OUT AND WAS CAUSING THE PATIENT PAIN. THE PHYSICIAN PREFORMED SCANS ON THE PATIENT BUT FOUND NO PROBLEMS. THE PATIENT WAS PUT UNDER ANESTHESIA FOR THE REMOVAL OF THE STENT. ONCE REMOVED IT WAS NOTED THAT THE STENT WAS KINKED. IT WAS REPORTED THAT THE PATIENT POST PROCEDURE WAS DOING WELL.
Patient problems: Awareness During Anesthesia; Pain
MAUDE report 6261308 ↗
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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