Bardex® I.C. Foley Catheter 0167SI16Recalls & reported problems
C. R. Bard, Inc. · Bardex® I.C. 30cc/ml Balloon Foley Catheter · Class 2
All models of Bardex I.C. Foley Catheter (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741017285), received between Dec 14, 2022 and Dec 14, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT WAS ASKED WHETHER THEY BELIEVE THE BENEFITS OF USING THE PRODUCT OUTWEIGH THE POTENTIAL RISKS IN RELATION TO THE BARDEX I.C. 3-WAY IRRIGATION FOLEY CATHETER AS PART OF A CUSTOMER SURVEY. THE RESPONDENT INDICATED THAT NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS. WHEN ASKED TO ELABORATE, THE RESPONDENT STATED URETHRAL INJURY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETHRAL INJURY (0167SI16, 0167SI18, 0167SI20, 0167SI22, 0167SI24, 0167SI26).
Patient problems: Tissue Breakdown
MAUDE report 15976227 ↗
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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