Dover 20518CRecalls & reported problems
Cardinal Health 200, LLC · 100 SILICONE FOLEY CATHETER, COUDE TIP, 5 CC, 2 WAY, 18 FR 6.0 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 10192253024272), received between Dec 18, 2025 and Dec 18, 2025 — 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
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON DEFLATES ON ITS OWN AND THE DEVICE HAS BEEN REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETER WAS INSTALLED ON (B)(6) 2025, AND IN THE AFTERNOON THE PATIENT HAD TO RETURN TO THE CLSC BECAUSE THE BALLOON DEFLATED, AND THE CATHETER FELL OFF. A NEW 18 FR CATHETER WAS RE-INSTALLED. ON (B)(6) 2025, RE-INSTALLED 18FR CATHETER ALSO HAD A BALLOON DEFLATION ISSUE AND IT WAS REPLACED BY ANOTHER 18 FR CATHETER AND THE ISSUE HAPPENED AGAIN WITH THE THIRD 18 FR CATHETER AS WELL. THE PATIENT HAD NO MEDICAL INTERVENTION OR TREATMENT, BUT THE PATIENT EXPERIENCED INCREASED INFECTION RISK AND SIGNIFICANT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 23843093 ↗
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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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