Leg BagRecalls & reported problems across all models
C. R. Bard, Inc. · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 345
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls
- 0
We found 17 models of Leg Bag by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 345 adverse event reports in the FDA's MAUDE database, received between May 10, 2017 and Sep 18, 2026 — classified as 51 injuries, 294 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (174 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Leg Bag problems
Device problems
- Restricted Flow rate174
- No Flow39
- Component Missing35
- Biocompatibility22
- Deformation Due to Compressive Stress12
- Device Operates Differently Than Expected11
- Obstruction of Flow11
- Adverse Event Without Identified Device or Use Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- No Known Impact Or Consequence To Patient102
- No Consequences Or Impact To Patient90
- Urinary Tract Infection34
- No Patient Involvement17
- No Information10
- Sepsis7
- Unspecified Infection7
Leg Bag models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Leg Bag 150819BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE102 reports
- Leg Bag 150832BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE100 reports
- Leg Bag 150719BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150732BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE24 reports
- Leg Bag 150632BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE18 reports
- Leg Bag 150419BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE15 reports
- Leg Bag 150103COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER14 reports
- Leg Bag 150102COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER13 reports
- Leg Bag 151932BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE7 reports
- Leg Bag 150619BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE6 reports
- Leg Bag 150432BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE6 reports
- Leg Bag 150932BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE5 reports
- Leg Bag 150332BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE4 reports
- Leg Bag 150319BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE3 reports
- Leg Bag 151919BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE2 reports
- Leg Bag 150919BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE1 report
- Leg Bag 4A4174BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE1 report
Recent Leg Bag adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionNov 18, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT PATIENT HAS ADVISED THAT SOME LEG BAGS WERE DISCOLORED INSIDE. ONE WAS COMPLETELY BLOCKED. RESULTING IN OVERFLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586259 ↗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 ↗MalfunctionOct 26, 2025Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT UNABLE TO DRAIN LEG BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23387917 ↗MalfunctionAug 5, 2025Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT, THE BED BAG WAS ATTACHED TO A STAND ON THE FLOOR SO IT SHOULD HAVE DRAINED AS NORMAL. CARER TRIED TO PASS SOME WATER THROUGH THE BAG WITH THE VALVE OPEN, UNFORTUNATELY THIS DID NOT HELP EITHER AND LIQUID WOULD STILL GOT STUCK IN THE TUBE. THERE WAS ANOTHER PROBLEM WITH ONE BAG, THE VALVE OF ONE BAG WHEN FIRST OPENED WOULD NOT MOVE AT ALL EVEN WITH A LOT OF FORCE SO IT COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715309 ↗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 ↗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 ↗MalfunctionMay 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT HAD ADVISED THE LEG BAGS WOULD NOT WORKING PROPERLY, THE TUBES KEPT TWISTING AND THE VALVE TAP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009546 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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