Dover 8887605148 (UDI 00884521147525)Recalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Catheter,5-10 mL, 2-Way · 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 00884521147525), received between Sep 30, 2024 and Feb 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
- Unintended Deflation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Unintended Deflation
THE CUSTOMER REPORTED THAT WHEN CHANGING AN SV MORNING, THEY HAD A PROBLEM WITH THE BALLOON OF THE PROBE. BALLOON TESTED BEFOREHAND BUT "EXPLODED" FIVE MINUTES AFTER FITTING WHILE STILL IN PLACE. THE BALLOON WAS INFLATED TO 10CC. NOTE: SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 24346835 ↗MalfunctionSep 30, 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 20335965 ↗
Other Tray, catheterization, sterile urethral, with or without catheter (kit) devices
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- 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.