Dover P4P16XSD (UDI 10192253031850)Recalls & reported problems
Cardinal Health 200, LLC · 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE · Class 2
All models of Dover (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10192253031850), received between Feb 13, 2025 and Feb 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation2
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.
MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND THE BALLOON WAS INFLATED PER MANUFACTURER INSTRUCTIONS. AT THE TIME OF CATHETER PLACEMENT AND BALLOON INFLATION, THERE WAS NO RESISTANCE NOTED. UPON SECURING THE FOLEY CATHETER TUBING TO THE PATIENT'S LEG, THE REGISTERED NURSE (RN) NOTICED THE FOLEY CATHETER HAD FALLEN OUT. UPON INSPECTION OF THE FOLEY CATHETER AND THE BALLOON TIP, IT APPEARED THAT THE BALLOON HAD POPPED. A NEW FOLEY CATHETER WAS OBTAINED AND PLACED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374383 ↗MalfunctionFeb 13, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT BALLOON INFLATED PER MANUFACTURING INSTRUCTIONS. NO RESISTANCE WAS NOTED ON INFLATION. THE SECUREMENT DEVICE DID NOT WORK AS CATHETER HAD FALLEN OUT. THE BALLOON APPEARED TO HAVE POPPED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374157 ↗
Other Urinary drainage collection kit devices
- Dover P4P14TSDCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall12 reports
- Dover P4P16CSDKCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall6 reports
- Dover P4P18CSDKCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6153Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6154Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6162MFCardinal Health, Inc. · Urinary Drainage Collection Kit18 reports
- Dover 6155MFCardinal Health, Inc. · Urinary Drainage Collection Kit4 reports
- Dover 6156MFCardinal Health, Inc. · Urinary drainage collection kit3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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