Leg Bag 150419Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741080654), received between Jan 30, 2018 and Mar 6, 2025 — classified as 2 injuries, 13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT LEG BAG DRAINAGE TAPS HAD BENT. PATIENT WAS CATHETERIZED ON (B)(6) 2025 USING BD CATHETER PACK. THEY REVIEWED THE PATIENT ON (B)(6) 2025 . THE CATHETER WAS NOT DRAINING PROPERLY, BLADDER SCAN 350MLS. IT MIGHT HAD BEEN RELATED TO A BENT CATHETER BAG TAP THAT WAS AFFECTING DRAINAGE. THEY DETACHED AND REAPPLIED CATHETER BAG INITIALLY BUT STILL DID NOT DRAIN. THEY THEN CHANGED THE CATHETER BAG, AND IT DRAINED PROPERLY.

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

  MAUDE report 21535389 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PHYSICIAN DISCOVERED THAT THE LEG BAG WAS DEFORMED WHEN OPENED BEFORE USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474271 ↗
• MalfunctionFeb 2, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BAG WAS WRINKLED AND THE URINATION VALVE WAS ATTACHED AT AN ANGLE. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 18JAN2023, STATED THAT NO URINE WAS ABLE TO BE DRAINED. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 24JAN2023, STATED THAT THE COMPLAINT WAS ABOUT THE BAG BEING WRINKLED AND THE URINARY DRAINAGE COCK BEING AT AN ANGLE, WITH NO MENTION OF URINE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282793 ↗
• MalfunctionJan 6, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BAG WAS WRINKLED AND THE URINATION VALVE WAS ATTACHED AT AN ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112123 ↗
• MalfunctionAug 30, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAGS WERE MISSING THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321389 ↗
• MalfunctionAug 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A VISITING NURSE CHECKED THE ACTUAL PRODUCT FOR A PATIENT AT HOME AND CONFIRMED THAT THE URINATION PORT OF THE LEG BAG WAS DISTORTED AND COULD NOT BE USED. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO IMPACT ON PATIENT AND LOOKED LIKE THERE WAS NO BENT AND TWISTED FROM THE PHOTO SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233982 ↗
• MalfunctionOct 28, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WERE NO LEG BAGS INSIDE THE BAG THAT THE CUSTOMER RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711992 ↗
• MalfunctionFeb 24, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAGS WERE MISSING FROM THE LEG STRAPS.

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

  MAUDE report 11372387 ↗
• InjuryDec 9, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT STATED THERE WAS NO TUBING WITH THE BAG AND ALSO STATED THAT THE BAG CAUSED URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10979001 ↗
• MalfunctionSep 10, 2020Restricted Flow rate; Leak/Splash; Infusion or Flow Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT GOING IN TO THE LEG BAG AND WAS BACKING UP IN THE TUBING , LEADING TO LEAK.

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

  MAUDE report 10518964 ↗
• MalfunctionDec 12, 2019Component Missing; Component Missing; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IT SHOULD BE 4 PIECES, BUT ONLY 3 PIECES WERE IN THE BOX.

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

  MAUDE report 9460498 ↗
• MalfunctionJul 19, 2019Component Missing; Component Missing; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER SHOULD HAVE RECEIVED FOUR DRAIN BAGS; HOWEVER; THE PATIENT RECEIVED ONLY ONE BAG IN THE BOX.

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

  MAUDE report 8807205 ↗
• MalfunctionJan 29, 2019Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS NOT DRAINING.

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

  MAUDE report 8285443 ↗
• MalfunctionOct 30, 2018Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE VALVE ON THE LEG BAG DID NOT ALLOW URINE TO FLOW OUT. THE PATIENT HAD TO MANIPULATE THE TUBING IN ORDER PASS THE URINE THROUGH. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8021239 ↗
• MalfunctionJan 30, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN INTO THE LEG BAG EVEN AFTER ALLEGEDLY PULLING THE VINYL APART FROM EACH OTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229264 ↗