Dover 50516TRecalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Catheter with Temperature Sensor,5 mL · 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 30884521149209), received between May 1, 2020 and Mar 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Failure to Deflate1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Obstruction of Flow; Failure to Deflate; Obstruction of Flow; Failure to Deflate
THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED HYPOTHERMIC, A TEMP SENSING FOLEY WAS PLACED. THE FOLEY WAS NOT DRAINING AND THE NURSING STAFF ATTEMPTED TO DEFLATE THE BALLOON AND WERE NOT ABLE TO DO SO. DOCTOR WAS MADE AWARE AND EVALUATED THE PATIENT, ULTIMATELY UROLOGY WAS CALLED FOR A CONSULT. PER UROLOGY, THE BRAND COVIDIEN (REF (B)(4). ) THAT THE HOSPITAL USED AS A REPLACEMENT FOR THE TEMP SENSING KITS IS KNOWN FOR HAVING OCCLUSIONS IN THE TUBING THAT GOES TO THE BALLOON. THE UROLOGY HAD TO CUT THE TEMP SENSOR AND REMOVE IT THEN PLACE A GUIDE WIRE THROUGH THE FOLEY TO POP THE BALLOON IN ORDER TO REMOVE THE CATHETER. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18916643 ↗MalfunctionMay 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING CAME APART WITH VERY LITTLE EFFORT, OPENING THE SYSTEM.. ON 1-MAY-2020 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CATHETER DETACHED FROM THE DRAINAGE BAG TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10018415 ↗
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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