UroForce Balloon Dilation CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 12 models of UroForce Balloon Dilation Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2017 and May 13, 2025 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 UroForce Balloon Dilation Catheter problems
Device problems
- Burst Container or Vessel10
- Inflation Problem6
- Material Rupture5
- Material Puncture/Hole3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Defective Device1
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions7
- No Patient Involvement5
- No Consequences Or Impact To Patient4
- Injury1
- Insufficient Information1
- Internal Organ Perforation1
- Patient Problem/Medical Problem1
UroForce Balloon Dilation Catheter models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UroForce® Balloon Dilation Catheter 888504DILATOR, CATHETER, URETERAL5 reports
- UroForce® Balloon Dilation Catheter 887504DILATOR, CATHETER, URETERAL4 reports
- UroForce® Balloon Dilation Catheter 888604DILATOR, CATHETER, URETERAL3 reports
- UroForce® Balloon Dilation Catheter 887510DILATOR, CATHETER, URETERAL2 reports
- UroForce® Balloon Dilation Catheter 887604DILATOR, CATHETER, URETERAL2 reports
- UroForce® Balloon Dilation Catheter 888806DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 888810DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 887404DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 887406DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 887410DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 887610DILATOR, CATHETER, URETERAL1 report
- UroForce® Balloon Dilation Catheter 887810DILATOR, CATHETER, URETERAL1 report
Recent UroForce Balloon Dilation Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT CUSTOMER BELIEVED THE TM STATED THE BALLOON DILATION CATHETER BURST ON A PREVIOUS USE AND SUBMITTED TO COMPLAINTS, BUT THEY WANTED TO SHARE JUST IN CASE. UROFORCE BALLOON DILATION CATHETERS WERE RECOMMENDED FOR DILATION OF THE URINARY TRACT. THIS WOULD BE CONSIDERED OFF LABEL. DISCUSSED HOW THE XFORCE N30 CATHETERS WERE RECOMMENDED FOR USE IN THE DILATION OF THE NEPHROSTOMY TRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009540 ↗MalfunctionJun 19, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS LEAKAGE IN BALLOON DILATION CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567011 ↗MalfunctionOct 11, 2023Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE CUSTOMER HAD A DEFECTIVE BALLOON DILATION CATHETER THAT WOULD NOT INSUFFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17912244 ↗MalfunctionJun 6, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THEY WERE NOT ABLE TO SUCCESSFULLY SUSTAIN AND/OR MONITOR PRESSURE WITH THE EAGLE INFLATION DEVICE. STATED THAT THE UROFORCE BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE WAS NOT SUCCESSFUL IN SUSTAINING AND/OR MONITORING PRESSURE BECAUSE OF LACK OF NURSING STAFF EXPERIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17069888 ↗InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA SURVEY RESPONSE THAT A MALE PEDIATRIC PATIENT (13 YEARS OLD) EXPERIENCED URINARY TRACT INFECTION AFTER PLACEMENT OF THE DEVICE, THIS COMPLICATION WAS DIRECTLY ATTRIBUTABLE TO USAGE OF BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE. URINARY TRACT INFECTION WAS PRESENT PRIOR TO PLACEMENT OF THE DEVICE, AND DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Urinary Tract Infection
MAUDE report 16953402 ↗MalfunctionSep 14, 2022Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS A LEAK IN A DILATION CATHETER BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417843 ↗MalfunctionFeb 24, 2022Partial Blockage; Inflation Problem; Partial Blockage; Inflation Problem
IT WAS REPORTED THAT THE DILATION CATHETER BALLOON WAS MALFUNCTIONING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01-FEB-2022, IT WAS REPORTED THAT THE DILATION CATHETER BALLOON WOULD NOT INFLATE. CUSTOMER STATED THAT NO MEDICAL CONCERNS RELATED TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13596354 ↗MalfunctionJan 12, 2021Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON DILATION CATHETER WAS INFLATED ABOUT 15ATM, AND THE BALLOON GOT BURST. IT WAS REPLACED WITH NEW PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11154967 ↗MalfunctionSep 2, 2020Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak
IT WAS REPORTED THAT THE BALLOON COULD NOT BE INFLATED. IT WAS ALSO STATED THAT THE ANOTHER CATHETER WAS USED. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01DEC2020 FROM INVESTIGATOR, IT WAS FOUND THAT THE BALLOON WAS TORN AND PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01DEC2020 FROM INVESTIGATOR, AS THE BALLOON COULD NOT BE INFLATED FOR A BALLOON DILATION CATHETER.
Patient problems: Insufficient Information; No Patient Involvement
MAUDE report 10483190 ↗MalfunctionJul 16, 2020Defective Device; Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE COMPLAINANT TRIED USING THE BALLOON DILATION CATHETER IN A CASE, BUT STATED THAT IT WAS DEFECTIVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10284823 ↗MalfunctionApr 9, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel
IT WAS REPORTED THAT DURING PRETEST, THE BALLOON RUPTURED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9942925 ↗MalfunctionDec 17, 2019Burst Container or Vessel
IT WAS REPORTED THAT THE CATHETER BALLOON BURST DURING PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9480277 ↗MalfunctionSep 3, 2019Inflation Problem; Leak/Splash
IT WAS REPORTED THAT THE BALLOON OF THE DILATION CATHETER COULD NOT BE INFLATED DUE TO A BALLOON LEAK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8957621 ↗InjuryFeb 28, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST. THE PATIENT'S URETER WAS DAMAGED AND REQUIRED TEMPORARY STENTING.
Patient problems: Patient Problem/Medical Problem; Tissue Damage
MAUDE report 8378347 ↗MalfunctionJan 17, 2019Inflation Problem; Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER COULD NOT BE INFLATED DURING A PRETEST.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8257516 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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