Leg Bag 150632Recalls & reported problems
C. R. Bard, Inc. · Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve (Leg Straps Not Included), Large (32oz). · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741050848), received between Nov 26, 2017 and Jun 14, 2021 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (13 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Restricted Flow rate13
- No Flow4
- Complete Blockage1
- Device Operates Differently Than Expected1
Patient problems
- No Patient Involvement8
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient3
- No Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPEN ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN AND IT WAS PILED OVER ON THE TOP. PER FOLLOW UP CALL ON 20MAY2021 IT WAS STATED THAT THE DRAIN BAGS HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996862 ↗MalfunctionJun 14, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPENING ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN, AND IT PILED OVER ON THE TOP. PER FOLLOW-UP CALL ON 20MAY2021, IT WAS REPORTED THAT THE DRAIN BAGS THAT HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996498 ↗MalfunctionJun 14, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPEN ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN AND IT WAS PILED OVER ON THE TOP. PER FOLLOW UP CALL ON (B)(6) 2021 IT WAS STATED THAT THE DRAIN BAGS HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996462 ↗MalfunctionJun 14, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPENING ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN, AND IT PILED OVER ON THE TOP. PER FOLLOW-UP CALL ON 20MAY2021, IT WAS REPORTED THAT THE DRAIN BAGS THAT HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996458 ↗MalfunctionJun 10, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPENING ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN, AND IT PILED OVER ON THE TOP. PER FOLLOW-UP CALL ON 20MAY2021: IT WAS REPORTED THAT THE DRAIN BAGS THAT HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980392 ↗MalfunctionJun 3, 2021Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPENING ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN, AND IT PILED OVER ON THE TOP. PER FOLLOW-UP CALL ON 20MAY2021, IT WAS REPORTED THAT THE DRAIN BAGS THAT HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11929923 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8970518 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8970511 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8970509 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8970387 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8970385 ↗MalfunctionSep 6, 2019Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW THE WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8969683 ↗MalfunctionSep 5, 2019Complete Blockage; Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING PRE-TESTING THE TUBING WOULD NOT ALLOW WATER TO FLOW INTO THE DRAIN BAG. THEREFORE, THE BAG WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 8966157 ↗MalfunctionNov 26, 2017No Flow
IT WAS REPORTED THAT THE COMPLAINANT TESTED THE BAG USING WATER, AND THE WATER WOULD NOT FLOW INTO THE BAG.
Patient problems: No Patient Involvement
MAUDE report 7058338 ↗MalfunctionNov 26, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE COMPLAINANT TESTED THE DEVICE USING WATER, AND THE WATER WOULD NOT FLOW INTO THE BAG.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7058334 ↗MalfunctionNov 26, 2017No Flow
IT WAS REPORTED THAT THE COMPLAINANT TESTED THE DEVICE USING WATER, AND THE WATER WOULD NOT FLOW INTO THE BAG.
Patient problems: No Information
MAUDE report 7058323 ↗MalfunctionNov 26, 2017No Flow
IT WAS REPORTED THAT THE COMPLAINANT TESTED THE BAG USING WATER, AND THE WATER WOULD NOT FLOW INTO THE BAG.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7058322 ↗MalfunctionNov 26, 2017No Flow
IT WAS REPORTED THAT THE COMPLAINANT TESTED THE DEVICE USING WATER, AND THE WATER WOULD NOT FLOW INTO THE BAG.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7058321 ↗
Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices
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- 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 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
- Leg Bag 150619C. R. Bard, Inc. · BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE6 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.
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