Bardex® Trattner Model Foley Catheter 600190LRecalls & reported problems
C. R. Bard, Inc. · Bardex® Trattner Model Foley Catheter Female Urethrographic Double Balloon Lubricious Coated · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741019289), received between Apr 29, 2021 and Jan 24, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Insufficient Device Problem Information1
- Material Fragmentation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN OPENED EACH OF THE TRATTNER CATHETER, THEY WERE BRITTLE AND HAD HOLES IN THEM. STATED THEY WEREN¿T OUTDATE UNTILL 31JAN2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16235597 ↗MalfunctionJan 24, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN OPENED EACH OF THE TRATTNER CATHETER, THEY WERE BRITTLE AND HAD HOLES IN THEM. STATED THEY WEREN¿T OUTDATED UNTIL (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16232694 ↗MalfunctionFeb 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE FEMALE URETHROGRAPHIC CATHETERS WERE NEEDED TO BE USED FOR A PATIENT AND ALL UNITS HAD DEFECTIVE BALLOONS, SO THE PATIENT¿S SURGERY HAD TO BE POSTPONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13546200 ↗MalfunctionApr 29, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE NURSE NOTICED RUPTURE IN THE INFLATION CATHETER BALLOON ON VISUAL INSPECTION WHEN THEY OPENED THE KIT. IT WAS STATED THAT 2 OF THE CATHETERS HAVE THE SAME ISSUE AND IT WAS NOT USED ON THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11748262 ↗
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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