Dover 6155MFRecalls & reported problems
Cardinal Health, Inc. · Latex Foley Catheter Tray,Closed System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521050549), received between Sep 4, 2020 and Oct 12, 2021 — classified as 4 malfunctions.
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
- Detachment of Device or Device Component1
- Material Rupture1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2021Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT ANTI-REFLUX DEVICE WAS STUCK INSIDE THE BAG'S INNER WALL WHEN THE PACKAGE WAS OPENED AND MAKING IT DIFFICULT FOR URINE TO FLOW THROUGH. THE ISSUE WAS NOTICED DURING USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12619261 ↗MalfunctionMay 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS NOT ATTACHED, POSSIBLY DUE TO THE CONNECTING PART COMING OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11872136 ↗MalfunctionOct 8, 2020Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED WHEN ATTEMPTING TO CHANGE THE CATHETER, WATER WAS UNABLE TO BE REMOVED FROM THE BALLOON. THE CATHETER WAS CUT TO REMOVE IT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10649111 ↗MalfunctionSep 4, 2020Material Rupture; Material Rupture
CUSTOMER REPORTS: THE CATHETER WAS INDWELT ON AND NEXT DAY THE BALLOON OF CATHETER WAS FOUND TO BE TORN IN THE DIAPER. THE CATHETER FRAGMENTED BUT WAS NOT RETAINED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10495429 ↗
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 6153Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6154Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover P4P18CSDKCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6162MFCardinal Health, Inc. · Urinary Drainage Collection Kit18 reports
- Dover 6156MFCardinal Health, Inc. · Urinary drainage collection kit3 reports
- Dover 7016MFCardinal Health, Inc. · Urinary Drainage Collection Kit2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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