Universa G49873Recalls & reported problems
Cook Incorporated · Universa Firm Ureteral Stent Set With Hydrophilic Coating · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002498730), received between Aug 3, 2017 and Aug 16, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Damaged Prior to Use2
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2017Device Damaged Prior to Use; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER. AS REPORTED AFTER THE UNIVERSA FIRM URETERAL STENT SET PACKAGE WAS OPENED IT WAS OBSERVED THAT THE WIRE GUIDE WAS DAMAGED. THIS DEVICE WAS NOT USED ON A PATIENT. NO ADVERSE EFFECTS TO A PATIENT AS THE DEVICE DID NOT MAKE CONTACT. ADDITIONAL DEVICE AND EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6796774 ↗MalfunctionAug 3, 2017Device Damaged Prior to Use; Device Damaged Prior to Use
THE USER FACILITY CONTACT REPORTED DURING A RIGHT URETEROSCOPY WITH STENT PLACEMENT, THE UNIVERSA FIRM URETERAL STENT SET WAS PINCHED SHUT AT THE PROXIMAL END OF THE STENT AND THEREFORE WOULD NOT PASS OVER THE WIRE GUIDE. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6763923 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page