Universa G49913Recalls & 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
- 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 10827002499130), received between Oct 25, 2017 and Sep 3, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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
- Device Damaged Prior to Use1
- Split1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
ADDITIONAL PATIENT OR EVENT INFORMATION HAS NOT BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 03SEP2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957025 ↗MalfunctionOct 25, 2017Split; Split
THE AREA REPRESENTATIVE REPORTED DURING AN ANTEGRADE PLACEMENT OF A URETERAL STENT, THE SURGEON USED THE UNIVERSA FIRM URETERAL STENT SET. WHEN THE SURGEON REMOVED THE TETHER, THE PIGTAIL WAS SPLIT. A NEW UNIVERSA STENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. AS REPORTED, THIS OCCURRED IN CONSECUTIVE CASES. THERE WAS NO PART OF THE DEVICE LEFT INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT. MANUFACTURER REPORT #¿S 1820334-2017-03616 (FIRST CASE) AND 1820334-2017-03617 (SECOND CASE) HAVE BEEN SUBMITTED TO CAPTURE THE CONSECUTIVE CASES IN WHICH THE PIGTAIL WAS SPLIT WHEN THE TETHER WAS REMOVED. THE SURGEON EXPRESSED THAT HE INTENSELY DISLIKES THE BRAIDED TETHERS THAT COME WITH THE UNIVERSA STENTS AND WOULD PREFER THEY COME WITH THE MONOFILAMENT TETHERS THAT ARE SOLD IN THE UNITED STATES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976254 ↗
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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