SureStep™ Foley Tray System Bardex® All- Silicone Foley Catheter Tray A897518Recalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bard Silicone Foley Catheter Tray with StatLock & 2000 ml Drainage Bag · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741073991), received between Dec 19, 2023 and Jan 9, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
Patient problems
- Exposure to Body Fluids1
- Hematuria1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CLINICIAN WAS CHANGING OUT THE GLOVES FROM THE KIT AND THE PATIENT WAS EXCRETING BLOOD IN URINE. WHEN THE FOLEY WAS CHANGED OUT AND THE REGISTERED NURSE REMOVED THE GLOVES THERE WAS THE PRESENCE OF THE BLOOD AND URINE ON THEIR HANDS. THEY CHECKED TO SEE IF THERE WERE ANY TEARS OR HOLES BUT COULD NOT FIND ANYTHING. REGISTERED NURSE DID NOT REQUIRE ANY DIAGNOSTIC TESTING. THEY JUST WASHED THEIR HANDS, AND THE MATERIAL MANAGEMENT ALSO STATED THAT THERE HAVE BEEN OTHER EVENTS WHICH HAD OCCURRED SIMILAR TO THIS EVENT WITHIN THE FACILITY AND THE GLOVES HAVE BEEN PULLED UNTIL FURTHER REVIEW. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Exposure to Body Fluids; Hematuria
MAUDE report 21112804 ↗MalfunctionDec 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOLEY TRAY STICKING TOGETHER AND SOMETIMES LEAKED . PER FOLLOW UP VIA EMAIL ON 29DEC2023, IT WAS REPORTED THAT THE ITEM WAS #A897518. DEFECT WAS FOUND PRIOR TO USE AND NO PATIENT WAS AFFECTED. THE TRAYS LEAKED LUBRICANT SOMETIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18355458 ↗
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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