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Universa G23404Recalls & 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
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002234045), received between Apr 28, 2016 and Feb 14, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

  • Break2
  • Material Separation2
  • Device Contamination with Chemical or Other Material1
  • Stretched1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2023Break; Break

    AS REPORTED, A UNIVERSA SOFT URETERAL STENT WAS DAMAGED. A UNIVERSA FIRM URETERAL STENT SET (PER DEVICE PACKAGING RETURNED WITH THE DEVICE) WAS RECEIVED 24JAN2023 WITH A SMALL SECTION OF THE STENT MISSING. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 16372102 ↗
  • MalfunctionOct 28, 2021Material Separation; Material Separation

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12711887 ↗
  • MalfunctionAug 28, 2018Break; Stretched; Break; Stretched

    IT WAS REPORTED AFTER A URETEROSCOPY (URS) OPERATION ON (B)(6) 2018, THEY PLACED THE UNIVERSA FIRM URETERAL STENT AND THE TETHER BROKE. AS REPORTED, THE TETHER WAS STRETCHING THEN BROKE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. FOLLOW UP INFORMATION WAS OBTAINED; DRAINAGE FROM THE KIDNEY WAS ACHIEVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7822753 ↗
  • MalfunctionAug 7, 2017Device Contamination with Chemical or Other Material

    WHEN PLACING THE URETERAL STENT OVER A .038 WIRE GUIDE, A "CREAMY GEL" SUBSTANCE WAS NOTICED BY THE USER. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6770250 ↗
  • InjuryApr 28, 2016Material Separation; Material Separation

    DURING A BILATERAL STENT PLACEMENT, THE TETHER STRETCHED AND BROKE INSIDE THE PATIENT. TETHER WAS REMOVED FROM PATIENT USING A GRASPER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Code Available

    MAUDE report 5615600 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

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