Bardia® Foley Catheter Insertion Tray for 5cc Balloon 802011Recalls & reported problems
C. R. Bard, Inc. · Bardia® Foley Catheter Insertion Tray for 5 cc Balloon · 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 00801741018305), received between Mar 25, 2020 and Apr 8, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Short Fill” (2 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.
Reports received per month
Most reported problems
Device problems
- Short Fill2
- Complete Blockage1
- Component Misassembled1
- Component Missing1
- Manufacturing, Packaging or Shipping Problem1
- Partial Blockage1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Short Fill; Short Fill
IT WAS REPORTED THAT THEY OPENED THE FOLEY CATHETER INSERTION TRAY, THE GLOVES WERE UNWRAPPED MEANING THEY WERE NOT STERILE AND THE SYRINGE WAS COMPLETELY EMPTY. THE CUSTOMER WOULD LIKE A REPLACEMENT AS SOON AS POSSIBLE SINCE THEY ONLY CARRY ONE AND THEY CANNOT USE THAT ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19060579 ↗MalfunctionApr 8, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THEY OPENED THE FOLEY CATHETER INSERTION TRAY, THE GLOVES WERE UNWRAPPED MEANING THEY WERE NOT STERILE AND THE SYRINGE WAS COMPLETELY EMPTY. THE CUSTOMER WOULD LIKE A REPLACEMENT AS SOON AS POSSIBLE SINCE THEY ONLY CARRY ONE AND THEY CANNOT USE THAT ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059534 ↗MalfunctionApr 23, 2020Partial Blockage; Partial Blockage; Complete Blockage
IT WAS REPORTED THAT THE SPECIMEN TUBE WAS CLOGGED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9992007 ↗MalfunctionMar 26, 2020Short Fill; Manufacturing, Packaging or Shipping Problem; Short Fill
IT WAS REPORTED THAT THE PATIENT RECEIVED INSERTION TRAYS WITH EMPTY SYRINGES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9886385 ↗MalfunctionMar 25, 2020Component Missing
IT WAS REPORTED THAT THE PATIENT STATED THE SYRINGES, WHICH CAME WITH HIS INSERTION TRAYS, DID NOT CONTAIN ANY SOLUTION FOR IRRIGATION. PER PHONE CALL WITH THE CUSTOMER ON (B)(6) 2020, HE STATED THAT SOMETIMES THERE WAS INK ON THE GLOVES, AND THE IODINE SWABS WERE MISSING.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9878348 ↗
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- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
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- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 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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