SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A307414ARecalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Lubri-Sil® IC Complete Care® Coude Catheter Tray & 350 ml Urine Meter · Class 2
All models of SureStep Foley Tray System Lubri-Sil IC Complete Care (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104374), received between Aug 8, 2024 and Apr 30, 2025 — classified as 2 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
- Material Puncture/Hole1
- Material Rupture1
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.
MalfunctionApr 30, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING THE INSTILLATION OF THE STERILE WATER. THE FOLEYS INADVERTENTLY CAME OUT OF THE PATIENT. THE SECOND TIME AROUND, THE CNL TESTED THE BALLOON AND NOTED IT LEAKING. THIS HAPPENED TWICE FOR THIS PATIENT - REQUIRING THE PATIENT TO RECEIVE A TOTAL OF 3 FOLEYS. THEY HAD THE DEFECTIVE PRODUCT AND TO SEND BACK. IT WAS NOTED THAT THE GIVEN LOT# WAS NGHY3201.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935214 ↗MalfunctionAug 8, 2024Component Missing; Component Missing
IT WAS REPORTED THAT NEW CONDOM CATHETER KITS DO NOT CONTAIN THE PERI WIPES IN THE KIT. THERE WAS A YELLOW STICKER ON THE BOTTOM STATED THERE ARE NO WIPES IN THE KIT. 14 FRENCH COUDE FOLEY KIT DID NOT CONTAIN LUBRICATION THERE WAS NO STICKER ATTACHED TO THIS KIT SAYING THERE WERE MISSING ITEMS. THE INTERMITTENT KITS WILL ALSO BE MISSING THE PRECLEANING WIPES FOR THE TIME BEING. THEY ALSO TOLD ME THERE WAS ONE KIT THAT DID NOT CONTAIN THE STERILE WATER SYRINGE TO INFLATE THE BALLOON BUT HAVE NOT SEEN THIS SO NOT SURE IF THIS WAS A ONE-TIME OCCURRENCE BUT TO KEEP IN MIND THAT THEY ARE RECEIVING MANY KITS FROM BARD WITH MISSING ESSENTIAL ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19940976 ↗
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
- 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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