Dover 8887688227Recalls & reported problems
Cardinal Health, Inc. · Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884521017072), received between Dec 19, 2023 and Dec 21, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Insufficient Flow or Under Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THE AFTER THE INSTALLATION, THE URINARY CATHETER DOES NOT EMPTY THE BLADDER. WHEN THIS CATHETER IS USED, THE BLADDER GETS FULL BUT DOES NOT EMPTY. THEY NOTICED IT QUICKLY AND CHANGED THE CATHETER IMMEDIATELY. THERE WAS NO HARM REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18375687 ↗MalfunctionDec 21, 2023Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THE AFTER THE INSTALLATION, THE URINARY CATHETER DOES NOT EMPTY THE BLADDER. WHEN THIS CATHETER IS USED, THE BLADDER GETS FULL BUT DOES NOT EMPTY. THEY NOTICED IT QUICKLY AND CHANGED THE CATHETER IMMEDIATELY. THERE WAS NO HARM REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18375679 ↗MalfunctionDec 19, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
THE CUSTOMER REPORTED AFTER INSTALLATION ON THE PATIENT, THE URINARY CATHETER DOES NOT EMPTY THE BLADDER. WITH THIS CATHETER, THE BLADDER GETS FULL BUT DOES NOT EMPTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18355397 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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