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Universa G53237Recalls & reported problems

Cook Incorporated · Universa, Silicone Foley Catheter 3-Way Closed End · Class 2

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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002532373), received between Dec 14, 2017 and Dec 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Blocked Connection” (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

  • Blocked Connection1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 14, 2017Blocked Connection; Blocked Connection

    CORRECTION: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THE REPORTED CATHETER THAT WOULD NOT DRAIN. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7118548 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources and updates

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