SureStep™ Foley Tray System Bard® Lubricath Foley A800060Recalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bard Lubricath Foley Catheter Tray - 2000 ml Drainage Bag · Class 2
All models of SureStep Foley Tray System Bard Lubricath Foley (7)
Data updated Oct 18, 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 00801741096624), received between Sep 10, 2019 and Jul 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Inadequate Instructions for Healthcare Professional1
- Short Fill1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2022Short Fill; Short Fill
IT WAS REPORTED THAT THERE WAS NO LUBE IN THE FOLEY SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14989301 ↗MalfunctionSep 10, 2019Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT OF THE TWO CASES ORDERED, ONE CASE ARRIVED LABELED AS A800060 BUT HAD A FEEDING PUMP SET INSIDE OF IT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8981445 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- Bardex® Lubricath® Foley Catheter 0165L16C. R. Bard, Inc. · CATHETER, COUDE539 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 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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