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Universa G53229Recalls & reported problems

Cook Incorporated · Universa, Silicone Foley Catheter Closed End · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002532298), received between Sep 5, 2018 and Sep 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Remove1

Patient problems

  • No Code Available1
  • Pain1
  • Vessel Or Plaque, Device Embedded In1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 5, 2018Difficult to Remove; Difficult to Remove

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Patient problems: No Code Available; Pain; Vessel Or Plaque, Device Embedded In

    MAUDE report 7847180 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.