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Dover 13716Recalls & reported problems

Cardinal Health, Inc. · Silicone Coated Latex Foley Catheter,Pre-connected Drainage Bag · 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 10884521051515), received between Jun 28, 2019 and Jun 28, 2019 — 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 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.

  • MalfunctionJun 28, 2019Difficult to Remove; Difficult to Remove

    THE CUSTOMER REPORTED A PATIENT HAD TO BE RETURNED TO THE OPERATING BLOCK TO REMOVE THE CATHETER/PROBE AS THE BALLOON WOULD NOT DEFLATE. A PIECE OF URETHRAL CATHETER WAS INTRODUCED TO TRY TO PIERCE THE BALLOON WITH NO SUCCESS. 10ML OF STERILE WATER WAS RE-INJECTED TO BURST THE BALLOON WITH NO SUCCESS. A CYSTOSCOPY WAS PERFORMED, AND THE PRESENCE OF THE INFLATED BALLOON WAS CONFIRMED. FORCEPS AND A GASTRIC BIOPSY WITH A NEEDLE WERE USED TO PIERCE THE CENTER OF THE BALLOON WHICH WAS SUCCESSFUL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8743654 ↗

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.