Bardia® Closed System Foley Catheter Tray 802018Recalls & reported problems
C. R. Bard, Inc. · Bardia® Closed System Foley Catheter Tray with Silicone Elastomer Coated Foley Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741019685), received between Oct 11, 2017 and Aug 18, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Component Missing” (4 reports).
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
- Component Missing4
- Burst Container or Vessel1
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BAGS AND CATHETER WERE MISSING FROM THE SHIPMENT IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249339 ↗MalfunctionNov 5, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON BURST AS THE NURSE WAS INSERTING IT INTO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9281084 ↗MalfunctionAug 26, 2019Component Missing; Component Missing
IT WAS REPORTED THAT THE BARDIA CATHETER TRAY WAS MISSING THE PRE-FILLED SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8933069 ↗MalfunctionOct 24, 2018Component Missing
IT WAS REPORTED THAT THE LUBRICATING JELLY WAS MISSING FROM THE CATHETER TRAY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8002203 ↗MalfunctionOct 11, 2017Component Missing
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CATHETER WAS MISSING.
Patient problems: No Patient Involvement
MAUDE report 6939998 ↗
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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