Leg Bag 150432Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741080661), received between Jul 11, 2017 and Sep 30, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Flow” (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.

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.

• MalfunctionSep 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DRAIN BAG PACKAGING WAS TORN. THE DEVICE WAS NOT USED BECAUSE THE EXTERIOR OF ONE OF THE FOUR PIECES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554942 ↗
• MalfunctionOct 9, 2019Restricted Flow rate; Obstruction of Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DID NOT DRAIN ALL THE WAY DOWN INTO THE LEG BAG.

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

  MAUDE report 9172296 ↗
• 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 8970383 ↗
• MalfunctionFeb 15, 2018No Flow

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN FROM THE CATHETER INTO THE LEG BAG UNLESS IT WAS A BRAND NEW BAG. THE COMPLAINANT ALLEGED THAT HE DISCONNECTED THE EXTENSION TUBING FROM THE LEG BAG TO ALLOW AIR INTO THE SYSTEM TO HELP URINE FLOW, BUT URINE STILL WOULD NOT DRAIN INTO THE BAG. THE COMPLAINANT ONLY EXPERIENCED THIS PROBLEM AFTER WASHING THE LEG BAG AND TRYING TO REUSE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273333 ↗
• MalfunctionFeb 3, 2018Device Inoperable; No Flow

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN INTO THE BAG AND HAD TO BE MANIPULATED TO WORK PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239953 ↗
• MalfunctionJul 11, 2017Component Missing

  IT WAS REPORTED THAT THE PACKAGING WAS MISSING THE LEG STRAPS.

  Patient problems: No Information

  MAUDE report 6704949 ↗