Leg Bag 150832Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00801741050886), received between May 10, 2017 and Sep 18, 2026 — classified as 11 injuries, 89 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829606 ↗
• MalfunctionSep 18, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829605 ↗
• MalfunctionSep 18, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829604 ↗
• MalfunctionAug 12, 2026Restricted Flow rate

  It was reported that three patients had recently experienced malfunctioning leg bags (Cat. 150832). The issue was reported over the past several days. No affected product was retained; however, staff were informed to save the product if the issue occurs again. It was reported that the one-way valve at the top of the leg bag prevented urine from draining into the bag. No injury or patient harm was reported. Three patients.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221646 ↗
• MalfunctionAug 12, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221645 ↗
• MalfunctionAug 11, 2026Restricted Flow rate

  It was reported that three patients had recently experienced malfunctioning leg bags (Cat. 150832). The issue was reported over the past several days. No affected product was retained; however, staff were informed to save the product if the issue occurs again. It was reported that the one-way valve at the top of the leg bag prevented urine from draining into the bag. No injury or patient harm was reported. Three patients.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216061 ↗
• MalfunctionMar 24, 2026Deformation Due to Compressive Stress

  PT SAID THAT THERE IS A CREASE IN THE EXTENSION TUBING AND THE URINE ISN'T FLOWING PROPERLY REPLACING THE LEG BAG. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677623 ↗
• MalfunctionNov 22, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAGS, AS A RESULT OF MEDICATION, HAVE RECENTLY BECOME INCONTINENT. THEY HAD BEEN USING THIS BARD DISPOSE-A-BAG LEG BAG (LARGE 32 OZ) ATTACHED TO SHIN, WITH A VARIETY OF EXTERNAL MALE CATHETERS. CUSTOMERS DRIVE SENIORS ALL DAY AND, THEREFORE, THE CUSTOMER IS SEATED IN THE CAR WHEN EMPTYING THEIR BLADDER. THEY ARE OFTEN UNABLE TO COMPLETELY EMPTY THE BAG IN A TIMELY MANNER. WHEN THEY PEE, THE TUBE FROM THE CATHETER TO THE BAG DOES NOT DRAIN AND A VACUUM FORMS BETWEEN THE CATHETER AND THE BAG. AS A RESULT, THE URINE BACKS UP IN THE CATHETER EVEN WHEN THEY ARE ABLE TO STAND AND THE URINE ¿DISSOLVES¿ THE CATHETER GLUE AND THE CATHETER DISCONNECTS FROM THE TUBING. OF COURSE, THERE WAS A RESULTING LEAK OR FLOOD. IN AN ATTEMPT TO SOLVE THIS, IF THEY HAVE TIME, THEY BRIEFLY LOOSEN THE CONNECTION FROM THE CATHETER TO THE TUBE ENOUGH TO ALLOW AIR INTO THE TUBE TO RELEASE THE VACUUM. THERE WERE TRIED INSERTING A SMALL TUBE INTO THE TUBE JUST WHERE IT ATTACHES TO THE MAIN TUBE AS SEEN HERE. IT DID NOT WORK, ONLY LEAKED AS THEY WERE USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759803 ↗
• MalfunctionSep 9, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG DID NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168826 ↗
• MalfunctionAug 28, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PRODUCT WAS PACKAGED IN A DIFFERENT OUTER PACKAGING AND LABELLING WAS FUNCTIONING DIFFERENTLY THAN THE ORIGINAL PRODUCT. AS PER THE FOLLOW-UP INFORMATION RECEIVED 08AUG2024, THE PATIENT'S WIFE FELT THAT THE PRODUCT CHANGED AS THE PACKAGING WAS DIFFERENT. THE ISSUE WITH THE PRODUCT WAS THAT THE WIFE (CARER) FELT THAT THE BARDIA BAG IN THE NEW PACKAGE HAD A WEAKER SECTION AT THE TOP OF THE PORT THAT MADE THE BAG KINK AT NIGHT. AS A RESULT, THE CARER FELT EXHAUSTED AS THEY WERE UP EVERY 2 HOURS DURING THE NIGHT ADJUSTING THE BAG TO ENCOURAGE DRAINAGE WHEN KINKED. THEY KNEW THAT THE CARER HAD SPOKEN TO 2 REPRESENTATIVES ABOUT THIS ISSUE, WHO HAD REINFORCED TO THE CLIENT/CARER THAT THE PRODUCT HAD NOT CHANGED DESPITE THE CHANGE IN PACKAGING. THE ISSUE WAS WITH ALL THE NEW PACKAGED BARIDA PRODUCTS. THE CARER CONTINUES TO USE THE PRODUCT DESPITE BEING OFFERED ALTERNATIVES AS THEY FEEL BARDIA IS THE BEST BRAND. THEY HAD NO ISSUES WITH BAGS PRIOR TO NEW PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085241 ↗
• MalfunctionAug 22, 2024Deformation Due to Compressive Stress; Wrong Label; Deformation Due to Compressive Stress; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT WAS PACKAGED IN A DIFFERENT OUTER PACKAGING AND LABELLING WAS FUNCTIONING DIFFERENTLY THAN THE ORIGINAL PRODUCT. AS PER THE FOLLOW-UP INFORMATION RECEIVED 08AUG2024, THE PATIENT'S WIFE FELT THAT THE PRODUCT CHANGED AS THE PACKAGING WAS DIFFERENT. THE ISSUE WITH THE PRODUCT WAS THAT THE WIFE (CARER) FELT THAT THE BARDIA BAG IN THE NEW PACKAGE HAD A WEAKER SECTION AT THE TOP OF THE PORT THAT MADE THE BAG KINK AT NIGHT. AS A RESULT, THE CARER FELT EXHAUSTED AS THEY WERE UP EVERY 2 HOURS DURING THE NIGHT ADJUSTING THE BAG TO ENCOURAGE DRAINAGE WHEN KINKED. THEY KNEW THAT THE CARER HAD SPOKEN TO 2 REPRESENTATIVES ABOUT THIS ISSUE, WHO HAD REINFORCED TO THE CLIENT/CARER THAT THE PRODUCT HAD NOT CHANGED DESPITE THE CHANGE IN PACKAGING. THE ISSUE WAS WITH ALL THE NEW PACKAGED BARIDA PRODUCTS. THE CARER CONTINUES TO USE THE PRODUCT DESPITE BEING OFFERED ALTERNATIVES AS THEY FEEL BARDIA IS THE BEST BRAND. THEY HAD NO ISSUES WITH BAGS PRIOR TO NEW PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024665 ↗
• MalfunctionAug 7, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT DRAINING ADEQUATELY. IT WAS GETTING STUCK THE MATERIAL WAS STICKING TOGETHER WHICH DID NOT ALLOW THE URINE TO DRAIN CAUSING SOME URINE TO BACK UP INTO THE CATHETER DRAINAGE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933701 ↗
• MalfunctionJun 19, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE LEG BAGS WERE DIFFICULT TO DRAIN OR THEY GOT CLOGGED AND HAD KINKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566422 ↗
• MalfunctionJun 18, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE INTERNAL SLEEVE OF LEG BAG KEEPS COLLAPSING. PER FOLLOW UP VIA PHONE ON 29MAY2024, IT WAS REPORTED THAT CUSTOMER HAS BEEN USING THE SAME BAGS FOR A LONG PERIOD OF TIME AND THEY SUDDENLY STOPPED WORKING PROPERLY. THE BAG COLLAPSED MEANING IT DID NOT ALLOW ANY URINE TO PASS THROUGH IT. CUSTOMER STATED THAT THEY PREFER TO USE A DIFFERENT TYPE OF BAG THAT WILL DRAIN THE URINE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561724 ↗
• MalfunctionApr 17, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LEG BAGS SEEM TO BE DEFECTIVE FROM LOT#: MGHT0472. THEY ARE GETTING CLOGGED AND FLATTENS AND THE MATERIAL SEEMS TO THICKER ON THIS BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124331 ↗
• MalfunctionApr 16, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG SLEEVE WAS FLATTENING OUT AND NOT LETTING THE VOID PASS THROUGH. THE REPRESENTATIVE WENT OVER OTHER OPTIONS BUT WANTED SAME BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117145 ↗
• MalfunctionMar 28, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT DRAINING INTO LEG BAG AND GOT STUCK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992951 ↗
• MalfunctionMar 26, 2024Restricted Flow rate; Restricted Flow rate

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

  Patient problems: Discomfort

  MAUDE report 18977836 ↗
• MalfunctionMar 13, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS GETTING STUCK IN THE TUBE AND NOT GOING INTO THE LEG BAG. IT DOES NOT NEED THE EXTENSION TUBING. THEY ALSO SAID THAT LIKED THE BUTTON STRAPS. PER CUSTOMER VIA PHONE ON (B)(6) 2024, IT WAS REPORTED THAT URINE STAYED IN THE TUBE AND LEAKED FROM THE TUBE CONNECTED TO THE CATHETER. THE PATIENT HAD CHANGED BAGS, AND THERE WAS NO LONGER AN ISSUE. THE BAG WAS THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893141 ↗
• MalfunctionDec 28, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PATIENT USED LEG BAG WITH THEIR CONDOM CATHETER. PATIENT ADVISED URINE WAS NOT DRAINED INTO THE LEG BAG BUT OVERFLOWED FROM THE TOP. THE CONDOM CATHETER WAS ADHERED TO PATIENT ANATOMY PROPERLY. REPRESENTATIVE EXPLAINED LEG BAGS WERE NOT VENTED AND SOMETIMES TEND TO AIR LOCK. THIS CAN BE REMEDIED BY DISCONNECTING THE BAG FROM THE TUBING AND BROKE THE AIR LOCK. IT WAS POSSIBLE THE BAG HAS A VAPOR LOCK THAT WAS CAUSED BY THE SIDES OF THE BAG STICKING TOGETHER. IF THIS HAPPENED, TRY SEPARATING THE SIDES OF THE BAG AWAY FROM EACH OTHER. SEPARATING THE SIDES OF THE BAG PRIOR TO USE MAY ALSO HELP PREVENT A VAPOR LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409090 ↗
• MalfunctionDec 21, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PATIENT WAS USING LEG BAG WITH CONDOM CATHETER. STATED THAT THE PATIENT ADVISED URINE WAS NOT DRAINING INTO THE LEG BAG AND STATED THAT THE URINE STAYS IN THE CATHETER AND TUBING CREATING PRESSURE THAT POPS OFF TUBING FROM CATHETER. REPRESENTATIVE EXPLAINED 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 18371579 ↗
• MalfunctionJul 26, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER DID NOT UNDERSTAND THE ANTI-REFLUX VALVE WAS NOT LETTING SOME OF THE LIQUID GO DOWN. CUSTOMER STATED THAT THEY LOOKED AT ANOTHER CLEAN, UNUSED BAG AND SAW THE VALVE INSIDE THAT NEEDED A LARGE AMOUNT OF PRESSURE TO OPEN. ALSO SAID THEY USUALLY USED A TISSUE TO HELP COLLECT ANY LIQUID TO PREVENT IT FROM SPILLING. REPRESENTATIVE ADVISED IT WAS A POSSIBLE VAPOR LOCK AND STATED THAT THERE WAS A FLUTTER VALVE ON THE INSIDE THAT OPENED UP TO LET URINE THROUGH AND THEN CLOSED TO PREVENT BACK FLOW INTO THE BLADDER. RESIDUAL LIQUID LEFT OVER MAY NOT BE ENOUGH PRESSURE TO PUSH FLUTTER VALVE OPEN WHICH COULD LEAD TO IT SITTING AT THE TOP OF THE TUBING THAT CONNECTED TO THE CATHETER, SUGGESTED NEEDING BETWEEN FINGERS TO ASSIST IN RELEASING LIQUID INTO BAG OR USING TISSUE TO CATCH RESIDUAL DURING CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396039 ↗
• MalfunctionJul 21, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAGS ARE LEAKING. PER FOLLOW UP VIA PHONE ON 05JULY2023, THE URINE WILL COME BACK UP THE TUBE INSTEAD OF FLOWING INTO THE BAG. PATIENT HAD TROUBLESHOOTING DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371294 ↗
• MalfunctionMar 20, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAG WAS BACKING UP AND WAS NOT DRAINING INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579300 ↗
• MalfunctionFeb 2, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE EXTENSION TUBING IN THE LEG BAG WAS MISSING FROM THE PACKAGE. CUSTOMER HAD TO USE THE EXTENSION TUBE FROM ANOTHER PACKAGE TO UTILIZE FIRST BAG. AS PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 25JAN2023, IT WAS STATED THAT THE LEG BAG DID NOT HAVE THE CONNECTING TUBE. AS PER FOLLOW-UP VIA PHONE ON 25JAN2023, IT WAS REPORTED THAT ONCE THEY PURCHASED THIS PRODUCT FROM THE LOCAL PHARMACY, IT WAS MISSING A PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282987 ↗