Dover 8887605163 (UDI 00884521147532)Recalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Catheter,5-10 mL, 2-Way · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884521147532), received between Apr 1, 2024 and Oct 8, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME CLOGGED DURING USE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396174 ↗MalfunctionSep 30, 2024Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME CLOGGED DURING USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340658 ↗MalfunctionSep 30, 2024Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME CLOGGED DURING USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339191 ↗MalfunctionApr 1, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS THAT THE BALLOON ON TWO FOLEYS HAS RUPTURED. ONE AFTER BEING IN FOR 2 WEEKS, AND ONE AFTER ONE WEEK. THIS CASE HAS BEEN PROCESSED FOR THE SECOND OCCURRENCE. THERE IS A SEPARATE CASE FOR THE FIRST OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014677 ↗MalfunctionApr 1, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS THAT THE BALLOON ON TWO FOLEYS HAS RUPTURED. ONE AFTER BEING IN FOR 2 WEEKS, AND ONE AFTER ONE WEEK. THIS CASE HAS BEEN PROCESSED FOR THE FIRST OCCURRENCE. THERE IS A SEPARATE CASE FOR THE SECOND OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014455 ↗
Other Tray, catheterization, sterile urethral, with or without catheter (kit) devices
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- Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A7044C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)54 reports
- Dover 3450LFCardinal Health, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall3 reports
- Dover 3450Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall1 report
- Dover 3408Cardinal Health 200, LLC · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 reports
- Dover 3420Cardinal Health, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 reports
- Dover 8887600784Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3410Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.