Leg Bag 150819Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00801741050879), received between Oct 18, 2017 and Oct 28, 2025 — classified as 27 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (61 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT GOT AIR LOCKS IN THEIR FOLEY CATHETER LEG BAG SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404548 ↗
• MalfunctionJul 1, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PATIENT STATED THEY WERE HAVING AN ISSUE WITH THE ADHESIVENESS, WHICH IS DUE TO THE WAY THAT THE LEG BAG DRAINING WHEN HE SITS. THEY STATED THAT WHEN THEY STANDS OR WALKS IT WORKS PROPERLY. ALSO STATED WHEN THEY WOULD SIT THE URINE WOULD BACK UP AND LEAK TO THE ADHESIVENESS WHICH CAUSED THE ADHESIVENESS TO COME OFF. THE PATIENT HAD TO GO THROUGH MORE CATHETERS DUE TO ISSUE WITH LEG BAGS. PATIENT CALLED BARD DIRECTLY AND REPORTED THE PROBLEM WITH THEM WHO SENT A BIOHAZARD BOX. THEY STILL HAS 2 LEG BAGS REMAINING. LOT #: NGJY2475 UNSURE IF MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371083 ↗
• MalfunctionSep 24, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CONDOM CATHETER CONNECTS TO THE LEG BAG. SOMETIMES THE URINE DID NOT FLOW INTO THE LEG BAG RIGHT AWAY. THE PATIENT SAID THAT THEY THOUGHT THAT THE DRAIN HOLE IN THE LEG BAG WAS TOO SMALL. URINE BACKS UP INTO THE TUBE. THIS CAUSES THE LEG BAG TO LEAK. PER CUSTOMER VIA PHONE ON (B)(6)2024, IT WAS REPORTED THAT CUSTOMER SAID THAT THEY DID NOT HAVE ANY LEG BAGS, AND CUSTOMER KNOWS NOTHING OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291147 ↗
• MalfunctionJul 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT VALVE BROKE OFF OF LEG BAG. PATIENT HAD USED THIS PRODUCT BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760119 ↗
• MalfunctionMay 6, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE URINE BACKED UP BUT WHEN THE PATIENT PULLED IN THE LEG BAG, THE LIQUID WILL ENTER. THEY WERE NOT SURE IF THEY USED THE LEG BAG CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247747 ↗
• MalfunctionMay 6, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LEG BAGS DID NOT WORK WELL. THE PATIENT PLACED THE BAG ON UPPER THIGH INSTEAD OF BELOW THE KNEE. WHEN URINATING THE CUSTOMER DESCRIBED BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247121 ↗
• MalfunctionMar 25, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PATIENT HAD BEEN EXPERIENCING ISSUES WITH THE CATHETER AND SAID THAT THE URINE WAS NOT DRAINING THROUGH THE TUBE AND WAS CREATING NEGATIVE PRESSURE WHICH WAS CAUSING DISCOMFORT AT THE TIP OF THE PENIS AND PATIENT CONCERNED ABOUT INFECTION WITH THIS. THEY INFORMED THEM TO TRY RUNNING WATER THROUGH THE LEG BAG FIRST, BECAUSE IT WAS LIKE A VACUUM AND CAUSING THE BACKFLOW AND WOULD FOLLOW UP WITH PATIENT TOMORROW. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 18967693 ↗
• MalfunctionFeb 21, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CONNECTOR AT THE END OF THE CONNECTION TUBING ON THE LEG BAG DOES NOT ALLOW URINE TO PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747484 ↗
• InjuryFeb 7, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE ALTHOUGH LEG BAG WAS HALF FULL, URINE WAS IN HOSE. THE PATIENT ALSO REPORTED HAVING PROBLEM WITH INFECTION, SAW DOCTOR WHO OBTAINED URINE SAMPLE AND PRESCRIBED MEDICATION. THE REPRESENTATIVE ADVISED THE PATIENT ON PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 18658322 ↗
• MalfunctionNov 15, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT CONNECTORS ON LEG BAGS MAY BE CLOGGED. WANTED TO KNOW HOW TO FIX. REPRESENTATIVE ADVISED SENDING DIFFERENT TUBING AND CONNECTORS OR SWITCH OUT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138780 ↗
• MalfunctionNov 1, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THEY WERE HAVING TROUBLE WITH URINE GOING THROUGH THE TUBE, THE PATIENT WAS NOT SURE IF IT WAS CATHETER CAUSING TROUBLE OR THE LEG BAG. PER FOLLOW UP VIA PHONE ON 25OCT2023, IT WAS REPORTED THAT THE CUSTOMER HAD THE INCORRECT SIZE OF 25MM AND NEEDS 21MM. PATIENT ALSO STATED THEY WERE HAVING DIFFICULTY USING THE PRODUCT AND THEY DIDN'T UNDERSTAND THE DIRECTIONS. CUSTOMER WAS ADVISED TO CONTACT LIBERATOR TO INQUIRE ABOUT GETTING THE CORRECT SIZE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046560 ↗
• MalfunctionMay 23, 2023Collapse; Restricted Flow rate; Collapse; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAGS DID NOT DRAIN PROPERLY FROM THE CATHETER. THE PATIENT STATED THAT AIR PREVENTS DRAINAGE AND BACK PRESSURE BLOWN OUT. PER FOLLOW UP VIA PHONE 01JUN2023, THE EXTENSION TUBING ON THE LEG BAG COLLAPSED WHEN THEY BEND THEIR LEG CAUSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984555 ↗
• MalfunctionJan 27, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG WAS NOT DRAINING THE URINE AND COLLECTS ON THE CATHETER. ANTI-REFLUX WAS PREVENTING IT FROM DRAINING PROPERLY AND THEY ARE BACKING UP INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253831 ↗
• MalfunctionNov 9, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS STALLING IN THE TUBING FOR THE PATIENT LEG BAG. BD REPRESENTATIVE EXPLAINED THAT THE LEG BAGS WERE NOT VENTED AND SOMETIMES TEND TO AIR LOCK, AND THIS COULD BE REMEDIED BY DISCONNECTING THE BAG FROM THE TUBING, AND BREAKING THE AIR LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759085 ↗
• MalfunctionFeb 22, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE HOSE AND 1 LEG STRAP WERE MISSING. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PRODUCTS MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578129 ↗
• InjuryFeb 18, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG WAS DEFECTIVE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS PRODUCT LESS THAN 90 DAYS. PER FOLLOW UP RECEIVED ON (B)(6) 2022, IT WAS STATED THAT THE LEG BAG WOULD NOT DRAIN FROM UPPER CHAMBER AND THE PATIENT HAD TWO LEG BAGS BLOW OUT BECAUSE THE URINE WOULD NOT DRAIN. THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AFTER THE SECOND BLOW OUT. THE DOCTOR PRESCRIBED PATIENT AN ANTIBIOTICS FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13562067 ↗
• MalfunctionFeb 18, 2022Restricted Flow rate; Insufficient Device Problem Information; Restricted Flow rate; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEG BAG WAS DEFECTIVE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS PRODUCT LESS THAN 90 DAYS. PER FOLLOW UP RECEIVED ON 27JAN2022, IT WAS STATED THAT THE LEG BAG WOULD NOT DRAIN FROM UPPER CHAMBER AND THE PATIENT HAD TWO LEG BAGS BLOW OUT BECAUSE THE URINE WOULD NOT DRAIN. THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AFTER THE SECOND BLOW OUT. THE DOCTOR PRESCRIBED PATIENT AN ANTIBIOTICS FOR THE URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13561102 ↗
• MalfunctionDec 3, 2021Inadequate or Insufficient Training; Illegible Information; Inadequate or Insufficient Training; Illegible Information

  IT WAS REPORTED THAT LEG BAG AND DRAIN BAG WERE LEAKING AT ALL THE CONNECTION POINTS FROM THE MALE EXTERNAL CATHETER TO THE BAGS. CUSTOMER ASKED HOW TO CONNECT IT. REPRESENTATIVE EXPLAINED CUSTOMER THAT THE CONNECTIONS WERE FRICTION FIT DEVICES WITH UNIVERSAL TRANSITION PARTS. AND WITHOUT A STRONG FORCE TO PUSH FRICTION FITTINGS TOGETHER, THE CONNECTIONS WOULD LIKELY COME LOOSE WITH LITTLE EFFORT, RESULTING IN LEAKS. ALSO, REPRESENTATIVE ADVISED TO SLIGHTLY TWIST CONNECTION BACK AND FORTH WHILE PUSHING DOWN TO HELP PROPERLY SEAT DRAINAGE CONNECTIONS. AND THE SAME ADVICE WOULD BE FOR THE BESIDE OR THE LEG BAG CONNECTIONS. THEY COULD NOT CONFIRM IF THE PATIENT WAS PUSHING THE MALE EXTERNAL CATHETER ONTO THE DRAIN BAG CONNECTOR AS FAR AS IT WOULD GO AND SUSPECTED THAT THE PARTS WERE NOT CONNECTED PROPERLY, OR THE TRANSITION CONNECTORS NOT GLUED INTO PLACE ON DRAINAGE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923658 ↗
• MalfunctionOct 14, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DID NOT FLOW INTO THE LEG BAG. THE USER STATED THAT THE LEG BAGS NEEDED TO HAVE SOME AIR SO THAT THE URINE COULD FLOW. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT MORE THAN 90 DAYS. PER FOLLOW UP VIA PHONE (B)(6) 2021, THE PATIENT HAD NOT BEEN USING THE LEG BAGS RECENTLY AND SOON GOING TO TRY THEM AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632629 ↗
• InjurySep 24, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ON THE LEG WHILE USING THE LEG BAG. THE PATIENT WAS TREATED BY A DOCTOR. THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 12525672 ↗
• MalfunctionSep 17, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE GREEN DRAIN TUBE WAS MISSING IN THE LEG BAG. CUSTOMER STATED THAT OVER THE LAST 3 MONTHS, 12 OF THE PRODUCTS WERE MISSING THE GREEN DRAIN TUBE. CUSTOMER USED THE PRODUCT WITHOUT THE TUBE. THE AFFECTED LOT NUMBERS ARE NGFP3229 AND NGFR0326.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487772 ↗
• MalfunctionSep 17, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE GREEN DRAIN TUBE WAS MISSING IN THE LEG BAG. CUSTOMER STATED THAT OVER THE LAST 3 MONTHS, 12 OF THE PRODUCTS WERE MISSING THE GREEN DRAIN TUBE. CUSTOMER USED THE PRODUCT WITHOUT THE TUBE. THE AFFECTED LOT NUMBERS ARE NGFP3229 AND NGFR0326.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487585 ↗
• MalfunctionSep 7, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS BACKING UP. THE REPRESENTATIVE DID TROUBLESHOOTING, ASKED ABOUT THE POSITION OF THE HOSE AND NOTED IT TO BE STRAIGHT. ALSO ASKED IF THE PATIENT HAD BLOWN ON THE BAG OR ADDED WATER TO SEPARATE THE INSIDE AND PROVIDED A FEW TIPS. THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436067 ↗
• MalfunctionJul 28, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS NOT DRAINING IN THE URINE TUBE. PER FOLLOW UP VIA PHONE ON 13JUL2021 IT WAS STATED THAT THE ONLY ADDITIONAL INFORMATION AVAILABLE WAS THAT THEY HAD TO CHANGE THEIR ENTIRE PROCESS BECAUSE THE LEG BAGS CAUSED SO MANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235963 ↗
• MalfunctionJul 27, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS NOT DRAINING OVERNIGHT AND CHANGED ON ANTI MERIDIAN. PER FOLLOW UP VIA PHONE ON (B)(6) 2021 IT WAS STATED THAT THE ONLY ADDITIONAL INFORMATION AVAILABLE WAS THEY HAD TO CHANGE THEIR ENTIRE PROCESS BECAUSE THE LEG BAGS CAUSED SO MANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231641 ↗