Bard Urinary Drainage BagRecalls & reported problems across all models

We found 6 models of Bard Urinary Drainage Bag by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 227 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Sep 28, 2026 — classified as 18 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (67 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

Most reported Bard Urinary Drainage Bag problems

Bard Urinary Drainage Bag models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® Urinary Drainage Bag 153509

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  91 reports
• Bard® Urinary Drainage Bag 153504

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  89 reports
• Bard® Urinary Drainage Bag 154004A

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  32 reports
• Bard® Urinary Drainage Bag 154114A

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  10 reports
• Bard® Urinary Drainage Bag 154005A

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  3 reports
• Bard® Urinary Drainage Bag 603402

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  2 reports

Recent Bard Urinary Drainage Bag adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924421 ↗
• MalfunctionSep 21, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848698 ↗
• MalfunctionSep 4, 2026Deformation Due to Compressive Stress

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 50612427 ↗
• MalfunctionAug 27, 2026Deformation Due to Compressive Stress

  It was reported that when the patient opened new package the Dome Bag hose had very tight crease on it. It was deep crease and urine would not pass through the tube that way.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485312 ↗
• MalfunctionJun 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THERE WAS URINARY LEAKAGE FROM THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479054 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INDIVIDUAL CUSTOMER REPORTED THAT ABOUT A WEEK AFTER FOLEY CATHETER PLACEMENT AT HOME, THEY EXPERIENCED URINE LEAKAGE FROM AROUND THE BASE OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409298 ↗
• MalfunctionMay 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE VALVE AND THE TUBE WAS LOOSE, CAUSING URINE TO LEAK OUT. WHEN HEALTH PROFESSIONAL PUSHED THE TUBE FIRMLY INTO THE VALVE, THE LEAK STOPPED. HEALTH PROFESSIONAL HAVE RECEIVED A REQUEST TO INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25265035 ↗
• MalfunctionMay 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE AFTER CATHETER INSERTION, URINE WAS LEAKING FROM AN UNIDENTIFIED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196022 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT URINARY LEAKAGE FROM THE BACK OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863136 ↗
• MalfunctionMar 24, 2026Restricted Flow rate

  IT WAS REPORTED BY THE CUSTOMER THAT THEIR CLIENT HAD COMPLAINED ABOUT URINE FLOWING BACK INTO THE TUBING. THEY WERE UNSURE IF THIS WAS NORMAL, AS THEY BELIEVED THE TUBING SHOULD HAVE BEEN ANTI REFLUX. THE CUSTOMER HAD REQUESTED CREDITS IN THE EVENT THAT FURTHER INVESTIGATION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682772 ↗
• InjuryFeb 20, 2026Disconnection

  IT WAS REPORTED THAT THE SAMPLE PORT FELL OUT OF CLOSED SYSTEM DRAIN BAG. A SPECIMEN PORT SPONTANEOUSLY FELL OUT OF THE SYSTEM'S DRAINAGE TUBING, RESULTING IN AN OPEN SYSTEM, AND REQUIRING A REINSERTION. CUSTOMER ALSO ATTACHED AN IMAGE BELOW SHOWING THE BLUE SPECIMEN/SAMPLE PORT HAVING SPONTANEOUSLY FELL OUT. STAFF REPORTED THEY DID NOT MANIPULATE THE PORT IN ANY WAY PRIOR TO FINDING IT LIKE THIS. IN THE IMAGE YOU CAN JUST MAKE OUT HOW THE STAFF FOUND THE DEVICE WITH THE BLUE VALVE SEPARATE FROM THE CATHETER DRAINAGE TUBING. CUSTOMER USED A STANDARD FOLEY DRAINAGE BAG. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 04FEB2026, IT WAS REPORTED THAT THE SOME OF THE LOT/SN INFORMATION HAD WORN/RUBBED OFF AND I WAS AND STILL AM UNABLE TO DECIPHER. THERE WAS PATIENT IMPACT RELATED TO THE USE OF THIS DEVICE AND THE MEDICAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. THE FOLEY HAD TO BE REMOVED. NO TROUBLESHOOTING WAS ATTEMPTED, THE SYSTEM WAS OPEN AND THE SPECIMEN PORT THAT ¿FELL OUT¿ AS CONTAMINATED AT THAT POINT, SO THE FOLEY HAD TO BE REMOVED.

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

  MAUDE report 24408100 ↗
• MalfunctionFeb 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THE TUBING WHERE IT GOES INTO THE BAG WAS BENT REALLY BAD (TWO BAGS) WOULDN'T DRAIN AND WOULDN'T STRAIGHTEN OUT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394235 ↗
• MalfunctionNov 25, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT IN OR DEPARTMENT, INSERTED ONE OF THESE FOLEY CATHETERS IN A PATIENT AND COULD NOT GET THE BALLOON TO INFLATE. THEY OPENED A 2ND TRAY AND HAD THE SAME ISSUE WITH THAT TRAY. THEY DID NOT KEEP ANY OF THE USED CATHETERS. THEY ONLY HAVE THE OUTER PACKAGES, BUT THEY DO NOT HAVE THE LOT NUMBERS ON THE OUTER PACKAGING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 17NOV2025, IT WAS REPORTED THAT THEY HAVE THE OUTER WRAPPERS FOR THE 2 FOLEY TRAYS, BUT UNFORTUNATELY THE STAFF DID NOT RETAIN THE DEFECTIVE CATHETERS. LOT NUMBER WAS NOT AVAILABLE. TWO URINARY CATHETER INSERTIONS WERE REQUIRED. REMOVAL AND REINSERTION OF URINARY CATHETER WERE PERFORMED. THEY WERE PERFORMED TROUBLESHOOTING. ATTEMPTED TO INSERT A FOLEY AND THE BALLOON WOULD NOT INFLATE. FOLEY REMOVED. OPENED ANOTHER FOLEY KIT AND WHILE TESTING THE BALLOON A LEAK WAS SEEN, AND THIS BALLOON WOULD ALSO NOT INFLATE. OPENED ANOTHER FOLEY KIT, BALLOON TESTED AND INFLATED APPROPRIATELY. FOLEY INSERTED AND THEN UNABLE TO DRAW URINE FROM THE PORT WITH SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645913 ↗
• InjuryNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS WAS A CASE OF URINE LEAKAGE FROM THE URINATION COCK OF THE DRAIN BAG. THE PATIENT CAME TO THE HOSPITAL BECAUSE OF THE LEAK AND HAD IT REPLACED.

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

  MAUDE report 23584798 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS URINE LEAKAGE FROM THE JOINT BETWEEN THE BAG AND THE TUBE. THE LEAKAGE WAS CONFIRMED DURING USE IN THE UROLOGY OUTPATIENT CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479504 ↗

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