Leg Bag 150719Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741050855), received between Dec 20, 2017 and Jan 29, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Component Missing” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN ADVERSE SKIN DERMATITIS REACTION TO THE CONTENTS IN THE BAG AROUND LEG. CUSTOMER HAD A BAD SKIN REACTION AFTER 3 TO 4 DAYS AFTER PLACEMENT ON BOTH LEGS. TWO OCCURRENCES OF THIS AS EACH LEG BAG HAD THIS ISSUE. EMERGENCY ROOM VISITED AND STEROIDS TO LOWER INFLAMMATION. CUSTOMER WANTED TO KNOW ACTIVE INGREDIENT IN THE BAG AS WELL HAD TRENDS IF THIS HAD OCCURRED WITH OTHER PATIENTS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21264800 ↗
• MalfunctionJul 16, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT LEG BAG WAS NOT ALLOWING URINE TO DRAIN INTO THE CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749570 ↗
• MalfunctionFeb 16, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER HAD ISSUES WITH LEG BAGS. THEY WERE SAYING THAT IT SEEMED LIKE SOMETHING WAS WRONG WITH THE VALVE AT THE TOP OF THE BAG, SO URINE WAS NOT DRAINING EASILY INTO THE BAG, BUT WAS EITHER BACKING UP INTO THE PATIENT FOLEY, OR DRAINED AT A TRICKLE INTO THE BAG. REPRESENTATIVE STATED THAT, IT SOUNDED LIKE IT MAY BE AIR LOCK WHICH DID SLOW DOWN DRAINING INTO THE BAG AND ASKED IF THE RN COULD MANIPULATE THE BAG TO ALLOW SOME AIR FLOW WITHIN THE DRAINAGE BAG PRIOR TO USE. CUSTOMER STATED THAT IT WAS NOT THE BAG ITSELF THAT WAS AIRLOCKED, IT WAS THE FLUTTER VALVE. THEY DID TEST ONE WHERE THEY ACTUALLY PUT AIR INTO THE VALVE AND BAG, THOUGHT THE SAME THING, AIRLOCKED. IT IMPROVED A LITTLE. CUSTOMER PUT ANOTHER ON THE PATIENT, MANIPULATING THE BAG TO GET SOME AIR IN THERE, AND IT WAS STILL NOT FLOWING THROUGH THE VALVE. PATIENT DRAINED TO AN OVERNIGHT BAG. CHANGED IT OUT TO A LEG BAG AND BACKED UP IN THE TUBING, PATIENT STARTED LEAKING AROUND CATHETER INSERTION. GOT ANOTHER LEG BAG AND MANIPULATED IT, GOT SOME AIR INTO IT AND STILL BACKED UP INTO TUBING. REPLACED WITH OVERNIGHT BAG. CUSTOMER HAD BOTH BAGS EMPTIED OF THE LITTLE URINE THAT DID DRAIN INTO THEM, BUT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720465 ↗
• MalfunctionMay 3, 2023Component Missing; No Apparent Adverse Event; Component Missing; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO HOSE TO CONNECT TO MALE EXTERNAL CATHETER TO LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860102 ↗
• MalfunctionApr 27, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE LEG BAG TUBING FOLDED OVER. CUSTOMER WOULD EMAIL PICTURES OF THE SECTION OF TUBING WHERE IT COLLAPSED. REPRESENTATIVE EXPLAINED THAT THEY SHOULD BE PLACING THE LEG BAG ON THE INSIDE OF LEG RATHER THAN THE OUTSIDE. ALSO ADVISED THEM TO ADD A LITTLE WATER TO THE LEG BAG INITIALLY TO OPEN IT UP A BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825222 ↗
• MalfunctionJan 25, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DID NOT DRAIN INTO THESE LEG BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241987 ↗
• MalfunctionOct 2, 2022Component Missing; No Apparent Adverse Event; Component Missing; No Apparent Adverse Event

  IT WAS REPORTED THAT THE LEG BAGS USE TO COME WITH TUBING, BUT NOW NONE OF THEM DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526264 ↗
• MalfunctionJun 16, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG WAS MISSING THE EXTENSION TUBING. THIS ISSUE HAD HAPPENED ON BOTH ORDERS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717809 ↗
• MalfunctionJun 16, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG WAS MISSING THE EXTENSION TUBING. THIS ISSUE HAD HAPPENED ON BOTH ORDERS 3061013 AND 3074184.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716544 ↗
• MalfunctionMay 20, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE TUBE WAS MISSING FROM THE LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461811 ↗
• MalfunctionMay 20, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE TUBE WAS MISSING FROM THE LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460142 ↗
• MalfunctionMay 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG DID NOT COME WITH TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434737 ↗
• MalfunctionApr 26, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO TUBING AND NO DRAIN VALVE ON THE LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212640 ↗
• MalfunctionMar 14, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG HAD NO TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758424 ↗
• MalfunctionMar 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE URINARY DRAIN BAG WAS LEAKING, AND THIS WAS THE SECOND TIME IT HAS HAPPENED, AND IT LEAKED NEAR THE TUBE OUTLET HUB. PER FOLLOW-UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE TWO BAGS WERE LEAKING AROUND THE EDGES OF THE CIRCLE AT THE BASE OF THE DRAIN TUBE. ALSO REPORTED THAT, THE PATIENT EXPERIENCED BLEEDING AND SEEPING SKIN FROM USING THE MALE EXTERNAL CATHETERS, AND THEY USED CLEANING PREP IN THE PAST BUT THAT DID NOT HELP WITH THE PROBLEM. PATIENT CONSULTED PHYSICIANS AND ASKED QUESTIONS, BUT NO SOLUTION WAS PROVIDED. NO MEDICAL INTERVENTION REPORTED. ALSO REPORTED THAT, THE PATIENT WAS CLEANING AND REUSING THE URINARY DRAIN BAGS AND QUESTIONED REGARDING CLEANING THE PRODUCT AND STATED THE TUBES WERE DIRTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685779 ↗
• MalfunctionOct 13, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG CONNECTOR TUBES WERE MISSING WHEN CUSTOMER RECEIVED THE RESHIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627053 ↗
• MalfunctionOct 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT LEG BAG CONNECTOR TUBING WAS MISSING UPON DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615376 ↗
• InjuryMar 18, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE LEG BAG CAUSED AN ALLERGIC REACTION ON THE LEG. PATIENT SAID THAT THE DOCTOR PRESCRIBED MEDICINE AND IT WAS CLEARED UP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11520992 ↗
• MalfunctionMar 26, 2020Restricted Flow rate; Connection Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT SAID THE LEG BAG DID NOT CONNECT TO THE DRAIN BAG LIKE HIS OTHER ONE DID. HE SAID URINE WAS NOT DRAINING INTO THE BAG, AND BACKED UP INTO THE CATHETERS.

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

  MAUDE report 9885450 ↗
• MalfunctionFeb 26, 2020Restricted Flow rate; Mechanical Jam; Restricted Flow rate

  THE PATIENT STATED THE LEG BAG HURT HIM AT NIGHT, AND HE HAD TO ADJUST THE BAG BECAUSE IT GOT STUCK. HE ALSO STATED THAT IT DID NOT FILL UP THE WAY IT SHOULD.

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

  MAUDE report 9757124 ↗
• MalfunctionNov 5, 2019Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN ITEM OTHER THAN WHAT THE PACKAGING WAS LABELED AS.

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

  MAUDE report 9281087 ↗
• MalfunctionAug 8, 2018Inadequate Instructions for Healthcare Professional; Component Missing; Inadequate Instructions for Non-Healthcare Professional; Component Missing

  IT WAS REPORTED THAT THE DRAIN BAG DID NOT COME WITH INSTRUCTIONS FOR USE.

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

  MAUDE report 7763439 ↗
• MalfunctionMar 29, 2018Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK WHERE THE DISPOS-A-BAG WAS CONNECTED TO THE T-TUBE (0099810). NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 7381506 ↗
• MalfunctionDec 20, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE OUTLET VALVE OF THE LEG BAG THAT PREVENTED URINE FROM BEING DRAINED OUT OF THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7132947 ↗