Dover 8887603101Recalls & reported problems
Cardinal Health, Inc. · Paediatric 100% Silicone Foley Catheter,3-5 mL, 2-Way · Class 2
All models of Dover (90)
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 10884521016620), received between Nov 20, 2020 and Oct 24, 2023 — classified as 2 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. 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
- Deflation Problem1
- Unintended Deflation1
Patient problems
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT WHEN SHE INFLATES THE BALLOON THERE WAS A HOLE IN IT. PER CUSTOMER, SHE ALWAYS TESTS PRIOR TO INSERTION. EACH TIME, SHE TESTED AND DIDN¿T NOTICE A HOLE AND INSERTED ONLY TO HAVE THE BALLOON SLOWLY DEFLATE AND FALL OUT, RESULTING IN A WET MESS. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17999715 ↗MalfunctionNov 20, 2020Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT WHEN THE BALLOON WAS INSERTED AND INFLATED, THE PATIENT EXPERIENCED INTENSE PAIN AFTER HALF AN HOUR AND SLIGHT BLEEDING IN THE PENIS. WHEN THE CATHETER WAS REMOVED, IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. AFTER SEVERAL ATTEMPTS, THE BALLOON WAS REMOVED, BUT DID NOT DEFLATE EVENLY WITH DIFFICULTY IN DEFLATING THE BALLOON TO REMOVE THE INJECTED SALINE. CONSEQUENCES TO THE PATIENT INCLUDED BLEEDING, PAIN, AND TRANSFER TO NECKER EMERGENCY ROOM.
Patient problems: Blood Loss; Pain
MAUDE report 10878480 ↗
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 8887600776Cardinal Health, Inc. · 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 3410Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 2480Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 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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