Universa G49867Recalls & reported problems
Cook Incorporated · Universa Firm Ureteral Stent Set 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002498679), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Calcified” (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
- Calcified1
- Patient Device Interaction Problem1
Patient problems
- Pain1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2022Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem
AS REPORTED, A UNIVERSA FIRM URETERAL STENT SET WAS PLACED IN THE PATIENT BECAUSE THEY HAD A URETERAL STONE. THE PATIENT HAD A FOLLOW UP VISIT SIX MONTHS AFTER STENT PLACEMENT AND USING ULTRASOUND IT WAS DISCOVERED THAT THE STENT WAS ENCRUSTED ON BOTH PIGTAILS (KIDNEY AND BLADDER LOOPS) AND ALSO ON THE STENT BODY. THE PATIENT WAS NOT URINATING WELL AND WAS IN PAIN AND THE STENT WAS REMOVED. THE PATIENT HAD TO UNDERGO A LASER LITHOTRIPSY PROCEDURE TO REMOVE THE ENCRUSTATIONS FROM THE STENT WITH THE LASER. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Pain; Unspecified Kidney or Urinary Problem
MAUDE report 13891529 ↗
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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