Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter 4A8116Recalls & reported problems
C. R. Bard, Inc. · Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter · Class 2
Data updated Oct 18, 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 00801741046483), received between Apr 26, 2017 and Apr 26, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.
Most reported problems
Device problems
- Difficult to Insert1
- Loose or Intermittent Connection1
Patient problems
- Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2017Difficult to Insert; Loose or Intermittent Connection
IT WAS REPORTED THAT THE COUDE TIP WAS NOT AS CURVED AS IT SHOULD BE. THE DEVICE WAS ALLEGEDLY DIFFICULT TO INSERT AND IRRITATION DEVELOPED.
Patient problems: Irritation
MAUDE report 6522921 ↗
Other Tray, catheterization, sterile urethral, with or without catheter (kit) devices
- Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5144C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)170 reports
- Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A7044C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)54 reports
- Dover 3450LFCardinal Health, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall3 reports
- Dover 3450Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall1 report
- Dover 3410Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600784Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600776Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3408Cardinal Health 200, LLC · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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