Leg Bag 150932Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741050909), received between May 14, 2018 and Nov 11, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THE CUSTOMER HAD ISSUES WITH THE BAGS. PER ADDITIONAL INFORMATION 30OCT2019, URINE DID NOT FLOW INTO THE BAG BUT IT WAS ABLE TO FLOW OUT OF THE BAG.

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

  MAUDE report 9305517 ↗
• MalfunctionJun 4, 2018Restricted Flow rate; Improper Flow or Infusion; Restricted Flow rate

  IT WAS REPORTED THAT URINE DRAINED INTO THE LEG BAG INITIALLY, THEN THE BAG WOULD NOT ALLOW ANY MORE URINE TO DRAIN INTO IT. IT WAS REPORTED THAT THE COMPLAINANT MASSAGED THE LEG BAG TO GET THE URINE TO DRAIN.

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

  MAUDE report 7566690 ↗
• MalfunctionJun 4, 2018Restricted Flow rate

  IT WAS REPORTED THAT URINE DRAINED INTO THE LEG BAG INITIALLY, THEN THE BAG DID NOT ALLOW ANY MORE URINE TO DRAIN INTO THE BAG. THE COMPLAINANT MASSAGED THE LEG BAG TO GET THE URINE TO DRAIN.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7566686 ↗
• InjuryMay 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLADDER INFECTION WHILE USING THE LEG BAG. IT WAS REPORTED THAT THE LEG BAG WAS RE-USED SINCE THE PATIENT HAD NO LEG BAGS LEFT TO USE. IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS, BUT DID NOT TAKE THEM.

  Patient problems: Unspecified Infection

  MAUDE report 7519902 ↗
• MalfunctionMay 14, 2018Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN INTO THE LEG BAG AFTER LESS THAN 12 HOURS OF USE.

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

  MAUDE report 7513122 ↗