SureStep™ Foley Tray System Bardex® Lubricath® Temp Sensing Coude Catheter A344916Recalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bardex® Lubricath® Temperature Sensing Coude Foley Catheter Tray 350 ml Urine Meter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741100512), received between Jul 26, 2018 and Jul 16, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Component Misassembled1
- Component Missing1
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Urinary Tract Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Component Missing; Component Misassembled; Component Missing; Component Misassembled
IT WAS REPORTED THAT THE INDWELLING FOLEY 16 FR COUDE TEMPERATURE SENSING CATHETER KIT WAS MISSING STERILE GLOVES IN PACKAGE. ALSO STATED THAT THE STERILE WATER SYRINGE WAS EMPTY, MISSING CAP (NOT FOUND IN KIT) AND PLUNGER WAS HALFWAY DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749236 ↗MalfunctionMay 22, 2024Fracture; Fracture
IT WAS REPORTED THAT 2 DIFFERENT FOLEY KITS WITH PROVIDED LOT#NGHZ0452 AND LOT# NGHX2265 WAS EXPERIENCING ISSUES WITH CRACKED STERILE WATER SYRINGES. PER FOLLOW UP VIA 08MAY2024, THE CLINICAL STAFF STATED THEY HAD OTHERS WITH THE SAME ISSUE BUT DID NOT SAVE THE PRODUCT OR LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19370398 ↗InjuryJul 26, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION WHILE USING THE FOLEY TRAY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Urinary Tract Infection
MAUDE report 7724591 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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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