Bardia® Foley Catheter Silicone Coated 123530ARecalls & reported problems
C. R. Bard, Inc. · Bardia® Foley Catheter, Silicone Coated, 5cc Balloon · Class 2
All models of Bardia Foley Catheter Silicone Coated (19)
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 00801741095160), received between Oct 16, 2018 and Oct 16, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Measurement System Incompatibility” (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.
Most reported problems
Device problems
- Measurement System Incompatibility1
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
- Irritation1
- Local Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Measurement System Incompatibility
IT WAS REPORTED THAT AFTER USE OF THE FOLEY CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED AN ALLERGIC REACTION. THE CATHETER WAS SUPRAPUBIC AND CHANGED EVERY MONTH. THE PATIENT WAS PRESCRIBED A CREAM FOR THE REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Irritation; Local Reaction
MAUDE report 7970070 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- Bardex® Lubricath® Foley Catheter 0165L16C. R. Bard, Inc. · CATHETER, COUDE539 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 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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