Skip to content

Universa G23382Recalls & 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 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002233826), received between Aug 9, 2017 and Aug 4, 2022 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment Of Device Component1
  • Device Operates Differently Than Expected1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 4, 2022Break; Break

    AS REPORTED, TWO UNIVERSA SOFT URETERAL STENTS FRAGMENTED WHILE INDWELLING IN THE PATIENT AND DURING REMOVAL (SEE PATIENT IDENTIFIER (B)(6) FOR OTHER DEVICE). THE DEVICE WAS PLACED IN THE LEFT URETER (B)(6) 2022 DURING A BILATERAL URETEROPLASTY AND STENT PLACEMENT. THE DEVICE FRAGMENTS WERE PERCUTANEOUSLY REMOVED FROM THE PATIENT (B)(6) 2022, AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. PHOTOS PROVIDED BY THE USER APPEAR TO SHOW MULTIPLE FISSURES AND CRACKS ALONG THE DEVICE FRAGMENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15169705 ↗
  • MalfunctionAug 9, 2017Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

    THE PHYSICIAN REPORTED DURING STENT PLACEMENT USING A 6 FR UNIVERSA SOFT URETERAL STENT SET, WHEN PLACING THE STENT WITH THE AID OF THE MONOFILAMENT STRING, THE STRING KEPT STRETCHING AND FINALLY THE STRING BROKE. A 7 FR UNIVERSA SOFT URETERAL STENT SET WAS THEN USED AND THE SAME ISSUE OCCURRED; THE MONOFILAMENT STRING STRETCHED AND FINALLY BROKE. AS REPORTED, NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THESE ISSUES. NO SECTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THESE ISSUES. ADDITIONAL PATIENT AND EVENT DETAIL HAS BEEN REQUESTED BUT NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. AS REPORTED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6778152 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page