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Dover 8948MFRecalls & reported problems

Cardinal Health, Inc. · Latex Foley Catheter Tray,Closed System · 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 10884521050662), received between Apr 27, 2021 and Apr 27, 2021 — 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 Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 27, 2021Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED APPROXIMATELY 7 CC OF WATER WAS DRAWN OUT VIA SYRINGE BUT NO ADDITIONAL WATER COULD BE DRAWN OUT OF THE CATHETER BALLOON AT THE TIME OF REMOVAL. THE PHYSICIAN SLOWLY PULLED OUT THE CATHETER AND THE BALLOON REMAINED SLIGHTLY INFLATED. NO PATIENT INJURY/HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11731451 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

All COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices →

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