Leg Bag 150619Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741050831), received between Aug 31, 2018 and Nov 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT PATIENT HAS ADVISED THAT SOME LEG BAGS WERE DISCOLORED INSIDE. ONE WAS COMPLETELY BLOCKED. RESULTING IN OVERFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586259 ↗
• MalfunctionAug 5, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT, THE BED BAG WAS ATTACHED TO A STAND ON THE FLOOR SO IT SHOULD HAVE DRAINED AS NORMAL. CARER TRIED TO PASS SOME WATER THROUGH THE BAG WITH THE VALVE OPEN, UNFORTUNATELY THIS DID NOT HELP EITHER AND LIQUID WOULD STILL GOT STUCK IN THE TUBE. THERE WAS ANOTHER PROBLEM WITH ONE BAG, THE VALVE OF ONE BAG WHEN FIRST OPENED WOULD NOT MOVE AT ALL EVEN WITH A LOT OF FORCE SO IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715309 ↗
• MalfunctionMay 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD ADVISED THE LEG BAGS WOULD NOT WORKING PROPERLY, THE TUBES KEPT TWISTING AND THE VALVE TAP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009546 ↗
• MalfunctionFeb 14, 2025Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THEY CHANGED LEGS BAGS SOMETIMES 2 TIMES A WEEK AS THE LEG BAG TUBE WAS BLOCKED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON04FEB2025, STATED THAT THE PATIENT THINKS THE BAG WAS BLOCKED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384651 ↗
• MalfunctionFeb 6, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT ADVISED THAT THEY ARE HAD ISSUES WITH THE LEG BAGS BLOCKING AND NOT DRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321523 ↗
• MalfunctionAug 31, 2018Restricted Flow rate; Fluid/Blood Leak; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG DOES NOT DRAIN PROPERLY. COMPLAINANT REPORTED THAT THE LEG BAG STOPS DRAINING WHEN URINE GETS TO THE VALVE AND THE PATIENT HAS TO MANIPULATE THE VALVE TO HAVE THE URINE FLOW INTO THE BAG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7839529 ↗