Dover 402714Recalls & reported problems
Cardinal Health 200, LLC · SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 5 CC, 2-WAY, 14 FR (4.7 MM) · Class 2
All models of Dover (45)
Data updated Oct 16, 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 10192253026627), received between Nov 30, 2022 and Aug 16, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Failure to Deflate3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Discomfort1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2023Failure to Deflate; Failure to Deflate
THE CUSTOMER REPORTED THE PROBE WAS USED TO PERFORM URINARY CATHETERIZATION. THE PROBE WAS CLAMPED WITH HEMOSTATIC FORCEPS DURING THE PROCEDURE. WHEN THE PROCEDURE WAS COMPLETED AND THE REMOVAL OF THE PROBE WAS REQUIRED, THE BALLOON COULD NOT BE EMPTIED OF ITS CONTENTS. THE PROBE HAD TO BE CUT UPSTREAM OF WHERE THE FORCEPS WERE PLACED IN ORDER TO EMPTY THE CONTENTS OF THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17556673 ↗MalfunctionDec 16, 2022Failure to Deflate; Failure to Deflate
THE CUSTOMER REPORTED THAT 2-3 WEEKS AGO IN THE TRAUMATOLOGY UNIT, THE BALLOON REMAINED INFLATED IN THE PATIENT. THIS REQUIRED CUTTING THE PATH OF THE BALLOON (WHICH DID NOT ALLOW THE CONTENTS OF THE BALLOON TO BE DRAINED), A CONSULTATION IN UROLOGY, AN ULTRASOUND, AND AN INTERVENTION IN RADIOLOGY TO RUPTURE THE BALLOON BY PIERCING IT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000736 ↗MalfunctionNov 30, 2022Failure to Deflate; Failure to Deflate
CUSTOMER REPORTS: WHEN THE FOLEY 14FR BLADDER CATHETER WAS REMOVED, THE BALLOON REMAINED INFLATED. THE NURSE WAS UNABLE TO REMOVE ALL THE LIQUID FROM THE BALLOON. THIS TIME, THE NURSE REALIZED IT WHEN THE CATHETER WAS REMOVED.
Patient problems: Discomfort
MAUDE report 15886637 ↗
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 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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