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Dover 2101Recalls & reported problems

Cardinal Health, Inc. · Hydrogel Coated Latex Foley Insertion Tray,Prep Deck · 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 10884521025554), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

  • Deflation Problem1

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.

  • MalfunctionNov 27, 2019Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED THAT THEY COULDN'T REMOVE ALL THE LIQUID FROM THE CATHETER'S BALLOON. THEY CUT THE CATHETER ABOVE THE Y SECTION BUT THE BALLOON DIDN¿T DEFLATE. WHEN THEY DID A VISUAL INSPECTION THEY REALIZED THE BALLOON HAD A DEFORMATION IN THE SUPERIOR SIDE. THEY CUT THE FOLEY ABOVE THE DEFORMATION WHICH ALLOWED THE BALLOON TO DEFLATE. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9383909 ↗

Other Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices

All Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices →

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