SureStep™ Foley Tray System with Bardex® Lubricath Temp Sensing Foley Catheter A119418MRecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bardex® Lubricath® Temperature Sensing Foley Catheter Tray 350 ml Urine Meter · 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 00801741073717), received between Jan 11, 2019 and Jan 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (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
- Erratic or Intermittent Display1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Temperature Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2019Erratic or Intermittent Display; Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem; Erratic or Intermittent Display
IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS NOT FUNCTIONING PROPERLY. REPORTEDLY, THE CATHETER WAS REPORTING LOW TEMPERATURES. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 8-JAN-2019 FROM BRIAN PRATT WHO REPORTED THAT "UPON PLACEMENT OR VERY SHORTLY THEREAFTER, TEMPERATURE READINGS WOULD BE VERY LOW OR FALL TO VERY LOW LEVEL. PHYSICAL CORRELATION WAS COMPLETED WHICH VERIFIED INCORRECT VALUES. "
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8242658 ↗
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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