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Dover P4P18TSRecalls & reported problems

Cardinal Health, Inc. · True content to be populated as part of rebranding · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521154305), received between Nov 15, 2021 and Nov 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER REPORTS: THE DEVICE HAS A DEFECTIVE TEMPERATURE SENSING FOLEY PRECISION CATHETER. THE RN FOUND IT DISCONNECTED WITH THE DRAINAGE BAG TUBING ON THE FLOOR THIS MORNING EVEN THOUGH THE TAMPER EVIDENT SEAL WAS INTACT AND NOT BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12900979 ↗
  • MalfunctionNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER REPORTS: THE DEVICE HAS A DEFECTIVE TEMPERATURE SENSING FOLEY PRECISION CATHETER. THE RN FOUND IT DISCONNECTED WITH THE DRAINAGE BAG TUBING ON THE FLOOR THIS MORNING EVEN THOUGH THE TAMPER EVIDENT SEAL WAS INTACT AND NOT BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12813180 ↗

Other DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE devices

All DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE devices →

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