Leg Bag 150103Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741050732), received between Jul 11, 2017 and Oct 26, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT UNABLE TO DRAIN LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387917 ↗
• MalfunctionNov 20, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE WANTED TO KNOW THE LENGTH OF THE 190Z AND 320Z LEG BAGS AND THE PATIENT HAD BEEN GETTING THE WHOLE TIME PER THE VENDOR, BUT THE MOST RECENT SHIPMENT SEEMS TO LONG TO FIT IN THE LEG BAG HOLDER THEY HAVE BEEN USING. (19OZ) - MEASURES 9.5 X 4.5 AND (32OZ) - MEASURES 12 X 4.75. THIS HAD CAUSED URINE TO BACK INTO THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733407 ↗
• MalfunctionApr 21, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT WAS MISSING THE CONNECTING TUBE IN THE LEG BAG. PER CLARIFICATION MAIL RECEIVED ON 08 FEB 2022, THE TUBING DID NOT COME WITH THE SHIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166325 ↗
• MalfunctionApr 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE LEG BAGS WHICH DID NOT HAVE SPOUTS OR CUT OFF VALVES. STATED THAT THERE WAS NO WAY TO EMPTY THE URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053400 ↗
• MalfunctionFeb 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT WANTED TO RETURN THE LEG BAG AS IT DID NOT HAVE TUBING AND ALSO PATIENT NEEDS VELCRO STRAPS. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PRODUCTS MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13565336 ↗
• MalfunctionDec 24, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A WAY TO EMPTY OUT THE LEG BAG, ON THE BOTTOM OF THE BAG AND THE UPPER TUBE DID NOT FIT INTO OR ONTO THE EXTERNAL. THE PATIENT USED EACH OF THE LEG BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13083172 ↗
• MalfunctionDec 17, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A WAY TO EMPTY OUT THE LEG BAG, ON THE BOTTOM OF THE BAG AND THE UPPER TUBE DID NOT FIT INTO OR ONTO THE EXTERNAL. THE PATIENT USED EACH OF THE LEG BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026157 ↗
• MalfunctionOct 20, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664393 ↗
• MalfunctionJun 3, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE BAG WAS BENT AT THE CONNECTION WITH THE TUBING WHICH RESULTED IN URINE BACK UP.

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

  MAUDE report 10113588 ↗
• MalfunctionNov 13, 2019Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE FLUTTER VALVE DID NOT ALLOW URINE TO DRAIN THROUGH THE TUBE INTO THE BAG.

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

  MAUDE report 9315913 ↗
• MalfunctionOct 9, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE FLUTTER VALVE DID NOT ALLOW URINE TO DRAIN THROUGH THE TUBE INTO THE BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173181 ↗
• MalfunctionJan 2, 2019Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT URINE BACKED UP IN THE TUBING AND DID NOT DRAIN INTO THE BAG.

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

  MAUDE report 8209815 ↗
• InjuryApr 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RASH ON HIS LEG FROM THE LEG BAG, FOR WHICH HE WENT TO THE EMERGENCY ROOM WHERE HE WAS PRESCRIBED A CREAM THAT WAS NOT OVER THE COUNTER.

  Patient problems: Rash

  MAUDE report 7434689 ↗
• MalfunctionJul 11, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A PINK FOREIGN MATERIAL AROUND THE OUTLET TUBE INSIDE OF THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6704831 ↗