Universa G23408Recalls & 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
- 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 10827002234083), received between Jan 11, 2017 and Jul 5, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
- Partial Blockage1
Patient problems
- Concussion1
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2017Partial Blockage; Partial Blockage
IT WAS REPORTED THAT PRIOR TO PERFORMING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN FOUND THAT THE TAPERED END THE UNIVERSA FIRM URETERAL STENT SET WAS CLOSED SHUT AND THEREFORE HE WAS UNABLE TO LOAD THE STENT ONTO THE WIRE. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED BUT AT THIS TIME IT IS NOT KNOWN IF THE PHYSICIAN USED ANOTHER STENT SET FROM SAME OR DIFFERENT LOT. THERE WAS NO KNOWN PATIENT HARM REPORTED DUE TO THIS OCCURRENCE.
Patient problems: Concussion; No Patient Involvement
MAUDE report 6685684 ↗InjuryJan 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED BY THE USER FACILITY THAT AFTER THE PLACEMENT OF THE STENT IT WAS SUCKED BACK UP INTO THE URETERAL ORIFICE AND THE SURGEON SPENT AN HOUR TRYING TO RETRIEVE THE STENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.
Patient problems: No Code Available
MAUDE report 6243230 ↗
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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