Leg Bag 150732Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741050862), received between Jun 26, 2017 and Jan 23, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT STATED THAT 3 OF HER 4 LEG BAGS ARE FOLDING AND STAYING FLAT AND NOT ALLOWING URINE TO FLOW. LOT # NGKR027. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172764 ↗
• MalfunctionJul 3, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT LEG BAG WAS NOT DRAINING. CUSTOMER BELIEVED THAT IT WAS A MOLDING ISSUE, AND IT HAPPENED 5 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396898 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THEY HAVE BEEN USING DRAIN BAG FOR MANY YEARS AND THEY FELT THAT THEIR EXPERIENCE WAS SUITABLE ENOUGH TO MAKE A VALID SUGGESTION AS TO THE ENGINEERING OF THE ABOVE BAG. IT WAS THEIR OPINION THAT THE HOLES FOR THE STRAPS SHOULD BE MADE MUCH WIDER LONGER TO ACCOMMODATE WIDER STRAPS. THE EXISTING STRAPS TWIST AND ROTATE CAUSING THE BAG TO CRIMP AND DISTURB URINE FLOW. THEY WALK MILES EVERY DAY AND MAYBE THEY SUBJECTED MINE TO GREATER STRESS, BUT THE FACT REMAINS, THAT IT HAPPENED MUCH TOO OFTEN. WIDER STRAPS WOULD LIE FLATTER AND HOLD THE BAG MORE SUITABLY. ALSO, THE NECK AT THE TOP OF THE BAG SHOULD BE MADE LONGER SO THE STRAP LIES OVER THE NECK AND NOT THE BAG. WHEN OVER THE BAG, IF TOO TIGHT, IT STOPS URINE FLOW. PERHAPS THEY COULD HAVE AN OFFER AN OPTION TO HAVE WIDE STRAPS OR NARROW STRAPS. PER CUSTOMER FOLLOW UP RECEIVED VIA EMAIL ON 29MAY2024, IT WAS REPORTED THAT FIRST OF ALL, THIS WAS NOT A COMPLAINT BUT A SUGGESTION FROM A LONGTIME USER TO IMPROVE THE BAG AND ATTACHED WAS THE FRONT SIDE OF THE BAG CONTAINER THAT SHOULD IDENTIFY THE PRODUCT. THE ONLY HARM WAS COMPLETE BLOCKAGE OF URINE FLOW IF THE STRAP CLOSES THE URINE FLOW OPENING. VERY BRIEFLY, IF THE

  Patient problems: Discomfort

  MAUDE report 20126146 ↗
• MalfunctionMay 3, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE URINE WAS CLOGGING AND BACKING UP IN LEG BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237103 ↗
• MalfunctionJun 19, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE LEG BAG HAD A KINK IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153053 ↗
• MalfunctionApr 10, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE LEG BAG SLIDES DOWN TO THEIR LEG AND CRINKLE THE BAG AND IN TURN, URINE DID NOT FLOW INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706896 ↗
• MalfunctionMar 6, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE FLIP FLOP LEG BAGS MISSING THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492960 ↗
• MalfunctionNov 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG DID NOT HAVE EXTENSION TUBING TO CONNECT TO THEIR CATHETER SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827322 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO URINARY TRACT INFECTIONS IN TWO DIFFERENT OCCASIONS. PATIENT WENT TO THE DOCTORS AND THEY TOLD IT WAS BECAUSE THE PATIENT DID NOT HAVE ENOUGH LEG BAGS. PATIENT WANTED TWELVE LEG BAGS EVERY NINETY DAYS. PATIENT SAID THEY WOULD BE ASKING THEIR DOCTOR TO SEND IN NEW PRESCRIPTION. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL ABOUT URINARY TRACT INFECTION. STATED THAT PATIENT WAS ON INTRAVENOUS ANTIBIOTICS (IV) AND ORAL ANTIBIOTICS. IT WAS ADVISED BY DOCTOR TO CHANGE THEIR LEG BAGS MORE FREQUENTLY, THEREFORE THE DOCTOR PRESCRIBED MORE BAGS FOR THE PATIENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 15579636 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SPENT FOUR DAYS IN THE HOSPITAL DUE TO THE URINARY TRACT INFECTION. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 14932948 ↗
• MalfunctionMay 25, 2022Component Missing; Component Missing

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496427 ↗
• MalfunctionMay 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CONNECTOR TUBE FROM THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427614 ↗
• MalfunctionNov 7, 2021Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO TUBING FOR THE LEG BAG. THE PATIENT HAD BEEN USING LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760656 ↗
• MalfunctionJul 14, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRATION DATE ON THE PRODUCT INSERT CARD DID NOT MATCH THE ONE OF THE LEG BAG ITSELF AND THAT EXPIRATION DATE ON CARD WAS 1996.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169478 ↗
• MalfunctionSep 4, 2020Missing Information

  IT WAS REPORTED THAT THE PATIENT JUST RECEIVED 9 CASES OF THE DRAIN BAG AND FOUND AS LATEX-FREE ON THE PACKAGING LABEL, BUT DID NOT FOUND ON THE INDIVIDUAL PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10497623 ↗
• MalfunctionJun 17, 2020Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT HAD TROUBLE WHILE USING LEG BAGS AND FELT LIKE THERE WAS A VACUUM AT THE TOP AND URINE SLOWLY TRICKLED INTO THE LEG BAG. IT WAS ALSO REPORTED THAT THERE WAS SOME BROWN SPOTS IN THE LEG BAG AND FACED NO ISSUES WITH THE DRAIN BAG. NO MEDICAL INTERVENTION REPORTED. PER FOLLOW UP, THE CUSTOMER STATED THE URINE DID NOT FLOW INTO THE BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165022 ↗
• MalfunctionJun 9, 2020Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PATIENT HAD TROUBLE WHILE USING LEG BAGS AND FELT LIKE THERE WAS A VACUUM AT THE TOP AND URINE SLOWLY TRICKLED INTO THE LEG BAG. IT WAS NOTED THAT THERE WERE SOME BROWN SPOTS IN THE LEG BAG AND FACED NO ISSUES WITH THE DRAIN BAG. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 10133768 ↗
• MalfunctionSep 5, 2019Restricted Flow rate; Infusion or Flow Problem; 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 Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8966148 ↗
• MalfunctionJan 2, 2019Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT FLOWING FROM THE CATHETER INTO THE DRAIN BAG, EVEN WHEN THE FLIP-FLO VALVE WAS OPENED. THE PATIENT ADVISED THAT SHE ALSO RECEIVED THE BAG WITHOUT ANY TUBING.

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

  MAUDE report 8209898 ↗
• MalfunctionDec 26, 2018Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE OUTER PACKAGING OF THE DRAIN BAG HAD A SLIT IN IT. THE ACTUAL DRAIN BAG WAS NOT DAMAGED.

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

  MAUDE report 8196998 ↗
• MalfunctionMar 28, 2018Misassembled; Melted; Misassembled; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DRAIN BAG HAD TO BE MANIPULATED TO DRAIN ONCE IT WAS FULL. IT WAS REPORTED THAT THERE WAS A PIECE OF PLASTIC MELTED OVER THE DRAIN HOLE.

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

  MAUDE report 7378769 ↗
• MalfunctionFeb 2, 2018No Flow

  IT WAS REPORTED THAT URINE WOULD NOT FLOW FROM THE TUBING INTO THE LEG BAG. THE PATIENT REPORTED THAT THE URINE BACKS UP IN THE TUBING AND CAUSES HIS MALE EXTERNAL CATHETER TO COME OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7237133 ↗
• MalfunctionDec 20, 2017Restricted Flow rate

  IT WAS REPORTED THAT URINE WILL NOT FLOW INTO THE LEG BAG ONCE IT REACHED 500CC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7132945 ↗
• MalfunctionJun 26, 2017No Flow

  IT WAS REPORTED THAT THE DRAIN BAG DEVELOPED A VAPOR LOCK AND DID NOT DRAIN PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669018 ↗