Dover 402716 (UDI 10192253026634)Recalls & reported problems
Cardinal Health 200, LLC · SILICONE ELASTOMER COATED LATEX FOLEY CATHETER, 5 CC, 2-WAY, 16 FR (5.3 MM) · Class 2
All models of Dover (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253026634), received between Feb 3, 2026 and Feb 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Deflation” (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
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Unintended Deflation
THE CUSTOMER REPORTED THAT THE CATHETERS SEEMED LIKE THERE WERE HOLES IN THE BALLOONS AND WOULD NOT STAY INFLATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT IT WAS ONLY ONE PATIENT WHO RECEIVED 3 INDIVIDUAL CATHETERS. THE ISSUE WAS NOTICED DURING CATHETER USE BY THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245827 ↗
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- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
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- 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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