Dover 145514Recalls & reported problems
Cardinal Health, Inc. · Urine Leg Bag · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521009766), received between Jan 24, 2022 and Jan 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED CREASES IN THE ANTI-REFLUX VALVE PREVENTED THE URINE FROM FLOWING THROUGH. NO INJURY WAS CAUSED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13333320 ↗
Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices
- Leg Bag 150819C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE102 reports
- Leg Bag 150832C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE100 reports
- Medline DYND12574Medline Industries, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE1 recall15 reports
- Leg Bag 150719C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150732C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150632C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE18 reports
- Leg Bag 150419C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE15 reports
- Leg Bag 151932C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE7 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page