Universa G23383Recalls & reported problems
Cook Incorporated · Universa Soft 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002233833), received between Feb 2, 2017 and Oct 20, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2017Break; Break
A VOLUNTARY MEDWATCH REPORT WAS RECEIVED. ACCORDING TO THE REPORT, A COOK MEDICAL UROLOGIC STENT WAS PLACED. AFTER THE STENT WITH A TETHER WAS PLACED, THE THIN TETHER BROKE, WHICH THEN REQUIRED THE STENT TO BE REMOVED, THE STENT TO BE RE-THREADED, AND THEN REPLACED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT REQUIRED ADDITIONAL ANESTHESIA TIME FOR THE REMOVAL, RE-STRINGING OF THE TETHER AND REPLACEMENT OF THE STENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6965222 ↗InjuryFeb 2, 2017Material Separation; Material Separation
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN URETEROSCOPY USING A UNIVERSA SOFT URETERAL STENT SET. THE ATTENDING PHYSICIAN TRIED TO REMOVE THE DEVICE FROM THE PATIENT WHEN THE TETHER BROKE. THE PHYSICIAN INDICATED HE WAS NOT FAMILIAR WITH THE TETHER ON THIS DEVICE BUT HE WAS MORE FAMILIAR WITH THE BRAIDED TETHER. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT BUT BY USING A GRASPER AND WAS ABLE TO FINISH THE PROCEDURE. NO UNINTENDED SECTIONS OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY NOR DID THE PATIENT EXPERIENCE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6295842 ↗
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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