SureStep™ Foley Tray System Bardex® All- Silicone Foley Catheter Tray A902414Recalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bard Silicone Foley Catheter Tray 350 ml Urine Meter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741074035), received between Sep 1, 2020 and Jan 7, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Leak/Splash1
- Material Puncture/Hole1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026
FOLEY CATHETER KIT MISSING 1 OF THE 3 SPONGES USED WITH BETADINE TO CLEAN URETHRAL AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989359 ↗MalfunctionDec 11, 2025Material Puncture/Hole
WHEN FLUSHING SALINE THE CONNECTED HAD A HOLE IN IT.
Patient problems: Insufficient Information
MAUDE report 23778317 ↗MalfunctionNov 6, 2025Leak/Splash
WHILE FILLING THE BALLOON OF A 14-FRENCH FOLEY CATHETER IN THE OR1 OF [REDACTED] HOSPITAL, THE FOLEY CATHETER LUMEN TUBING HAD A LEAK. THIS WAS CAUGHT WHILE FILLING THE BALLOON. THE 10CC SYRINGE NORMAL SALINE FLUID BURST UPWARD AT THE DOUBLE LUMEN SITE. THE PATIENT WAS NOT INJURED. NO NORMAL SALINE FLUID LEAKED INSIDE THE PATIENT. THE FOLEY CATHETER TIP/BALLOON WAS INTACT ONCE PROMPTLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485634 ↗MalfunctionSep 1, 2020Product Quality Problem; Component Missing; Component Missing
IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED 3 CLEANING SWABS WERE MISSING FROM THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10476605 ↗
Other CATHETER, URETHRAL devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82144Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
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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