Universa G49982Recalls & reported problems
Cook Incorporated · Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating · Class 2 · Implant
All models of Universa (82)
Data updated Oct 18, 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 10827002499826), received between Dec 28, 2017 and Dec 28, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operational Issue” (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 18, 2026.
Most reported problems
Device problems
- Device Operational Issue1
Patient problems
- Calcium Deposits/Calcification1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 28, 2017Device Operational Issue; Device Operational Issue
STENT HAD BEEN IMPLANTED NEARLY 5 MONTHS AT TIME OF THE ATTEMPTED RETRIEVAL. THE DOCTOR CUT THE STENT IN HALF AND RETRIEVED ONE HALF OF THE STENT, THE OTHER HALF REMAINED IN THE PATIENT¿S BODY. THE PATIENT EMOTIONALLY SUFFERED DUE TO HAVING TO BE ADMITTED TO THE HOSPITAL AGAIN AND IS FEELING STRESSED TO GO THROUGH ANOTHER PROCEDURE.
Patient problems: Calcium Deposits/Calcification
MAUDE report 7151014 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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