Universa G49909Recalls & reported problems
Cook Incorporated · Universa Firm Ureteral Stent and Positioner With Hydrophilic Coating · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002499093), received between May 10, 2017 and May 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Torn Material” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Torn Material1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2017Torn Material; Torn Material
IT WAS REPORTED THAT PRIOR TO USE/PATIENT CONTACT FOR AN UNSPECIFIED PROCEDURE, THE USER DISCOVERED AN ANGLE TEAR AT THE SECOND INK BAND ON THE STENT. THE DEVICE IN USE WAS A UNIVERSAL FIRM URETERAL STENT SET. THE DESCRIPTION OF THE EVENT CAME FROM THE PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE. PHOTOS WERE RECEIVED OF THE DEFECTIVE PRODUCT SHOWING WHERE THE TEAR BEGAN, STARTING AT THE SIDE-PORT. THE REPORT STATED THAT THE STENT WAS TORN DURING REMOVAL OF THE TETHER. IT WAS NOTED THAT THE PROXIMAL COIL OF THE STENT WAS TORN 2 CM FROM END OF THE COIL AT 2ND INK BAND AND THROUGH THE, FIRST SIDE PORT. NO FURTHER INFORMATION WAS PROVIDED, ADDITIONALLY QUESTIONS HAVE BEEN SENT TO THE CUSTOMER TO PROVIDE MORE INFORMATION.
Patient problems: No Patient Involvement
MAUDE report 6556768 ↗
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.
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