Dover 3560Recalls & reported problems
Cardinal Health 200, LLC · SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 16 FR (5.3 MM) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253026344), received between Nov 3, 2023 and May 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (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
- Unintended Deflation3
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PER CUSTOMER, THE PATIENT STATED THAT THE CATHETER BROKE/ RIPPED APART WHILE IN USE. EACH CATHETER BROKE IN A SIMILAR AREA (NOT FAR FROM THE INSERTION POINT). THIS ALL HAPPENED WITHIN THE SAME MONTH RESULTING IN THE PATIENT NEEDING A CATHETER INSERTION 3 TIMES WITHIN A 3-WEEK PERIOD. THE PATIENT NEEDED TO SEEK MEDICAL ASSISTANCE TO RETRIEVE THE 2ND BROKEN CATHETER. 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 19273712 ↗MalfunctionApr 3, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THERE WAS A HOLE IN THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034102 ↗MalfunctionNov 15, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED RESULTING IN THE PATIENT GOING TO THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18142762 ↗MalfunctionNov 3, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON BURST CAUSING THE PATIENT TO HAVE GO TO THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 18067914 ↗
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- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
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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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