Universa G23417Recalls & 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
- 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 10827002234175), received between Jun 25, 2019 and Jun 25, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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
- Detachment of Device or Device Component3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS ORIGINALLY REPORTED DURING KIDNEY/URETER STENT PLACEMENT USING A UNIVERSA FIRM URETERAL STENT SET, THE "STRING LOOSENS AT THE SLIGHTEST TOUCH." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. PHYSICAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE TETHER ON THE DEVICE IS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8732598 ↗MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED ON 25JUN2019: IT WAS REPORTED, THE TETHERS ARE BREAKING AT THE KNOTS BY THE SLIGHTEST TOUCH. THE STENTS WERE TESTED BY THE ACCOUNT AND FOUND THAT THE TETHER BREAKS EASILY AND THESE TETHERS WERE NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8732178 ↗MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED ON 25JUN2019: IT WAS REPORTED, THE TETHERS ARE BREAKING AT THE KNOTS BY THE SLIGHTEST TOUCH. THE STENTS WERE TESTED BY THE ACCOUNT AND FOUND THAT THE TETHER BREAKS EASILY AND THESE TETHERS WERE NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8731626 ↗
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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