Dover 20516C (UDI 10884521015951)Recalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Catheter,Coude Tip, 5 mL, 2-Way · Class 2
All models of Dover (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521015951), received between Oct 23, 2024 and Oct 31, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (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. 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 Deflation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2024Unintended Deflation; Unintended Deflation
PER CUSTOMER, THE HEAD OF THE UNIT HAVE DONE TEST WITH ONE CATHETER AND THE BALLOON LOST VOLUME OVER TIME. AFTER 1 WEEK, THE VOLUME WENT FROM 10 ML TO 3ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579376 ↗MalfunctionOct 23, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON EMPTIES VERY OFTEN, AND THEY FIND THE CATHETER IN THE BED A FEW DAYS AFTER INSTALLATION. THERE WAS NO PATIENT HARM REPORTED. PER CUSTOMER, THE HEAD OF THE UNIT HAVE DONE TEST WITH THE CATHETER BALLOON AND THE BALLOON LOST VOLUME OVER TIME. AFTER 1 WEEK, THE VOLUME WENT FROM 10 ML TO 3ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515499 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page