SureStep™ Foley Tray System Bardex® IC Complete Care® A300314ARecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bardex® IC Complete Care® Tray & 2000 ml Drainage Bag · Class 2
All models of SureStep Foley Tray System Bardex IC Complete Care (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741073724), received between May 4, 2023 and Feb 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Jun 25, 2026Class IIOpen, Classified
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Z-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 5, 2021Class IIOpen, Classified
There is potential for packaging defects that may impact the sterile barrier.
Z-2522-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT FOLEY TRAY HAD A LUBRICANT SYRINGE WITH NO LUBE IN IT AND HAD NO CAP ON THE SYRINGE. THEY STATED THEY HAVE FOUND THIS BEFORE IN THE TRAYS, BUT WE DO NOT HAVE THE LOT NUMBERS FROM THOSE ONES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777616 ↗MalfunctionMay 4, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT BELOW THE TIP OF THE SYRINGE SNAPPED OFF IN THE BALLOON PORT IN THE FOLEY CATHETER. AS PER FOLLOW UP VIA EMAIL ON 18APR2023, IT WAS REPORTED THAT THE PATIENT WAS ON CONTACT ISOLATION AND THE SAMPLE WAS NOT SAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16868154 ↗
Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3,889 reports
- Bardex® I.C. Foley Catheter 0165SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 reports
- Bardex® I.C. Foley Catheter 0165SI16C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® I.C. Temperature Sensing Foley Catheter 129414MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119316MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES231 reports
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES198 reports
- Bardex® I.C. Foley Catheter 0165SI18C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 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 · each recall links to the FDA recall notice
- 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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