Universa G49901Recalls & reported problems
Cook Incorporated · Universa Firm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002499017), received between May 13, 2016 and Aug 23, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Knotted” (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
- Knotted2
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2019Material Deformation; Material Deformation
NO NEW PATIENT OR EVENT INFORMATION TO BE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8925517 ↗MalfunctionMay 13, 2016Knotted; Knotted
A CYSTOSCOPY, RETROGRADE PYELOGRAM, URETEROSCOPY, RIGHT ESWL PROCEDURE WAS BEING PERFORMED ON THE (B)(6) MALE PATIENT WITH A PRE-EXISTING CONDITION OF RENAL STONE. THE CYSTOSCOPE WAS INTRODUCED AND THE RIGHT URETERAL ORIFICE WAS GRASPED AND BROUGHT DOWN. A PORTION CAME OUT AND THERE WAS A SLIGHT HANG UP. RE-CYSTOSCOPY SHOWED THAT THERE HAD BEEN A LOOP CAUGHT AS IT COILED BACK ON ITSELF AND THE STENT. WITH GRADUAL TRACTION, THIS EASILY RELEASED, CAME THROUGH THE RIGHT URETERAL ORIFICE AND WAS REMOVED. THE PATIENT DID NOT REQUIRE AND ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5653760 ↗MalfunctionMay 13, 2016Knotted; Knotted
A CYSTOSCOPY, RETROGRADE PYELOGRAM, URETEROSCOPY, STONE REMOVAL, STENT EXCHANGE PROCEDURE WAS BEING PERFORMED ON THE (B)(6) YEAR OLD MALE PATIENT. A KNOT WAS VISUALIZED AT THE PROXIMAL END OF THE STENT IN KIDNEY VIA URETEROSCOPY. THE KNOT WAS ABLE TO BE STRAIGHTENED OUT AND GUIDED OUT USING THE URETEROSCOPE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5653717 ↗
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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