Bard X-Force Balloon Dilation CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 231
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 22 models of Bard X-Force Balloon Dilation Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 231 adverse event reports in the FDA's MAUDE database, received between Apr 3, 2017 and Sep 30, 2026 — classified as 17 injuries, 214 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 Bard X-Force Balloon Dilation Catheter problems
Device problems
- Fluid/Blood Leak61
- Inflation Problem35
- Burst Container or Vessel32
- Material Fragmentation23
- Leak/Splash19
- Break18
- Material Rupture18
- Component Misassembled17
Patient problems
- No Clinical Signs, Symptoms or Conditions125
- No Known Impact Or Consequence To Patient75
- No Consequences Or Impact To Patient59
- No Patient Involvement20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Exposure to Body Fluids7
- No Information7
- Perforation3
Bard X-Force Balloon Dilation Catheter models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® X-Force® Balloon Dilation Catheter 998706DILATOR, CATHETER, URETERAL38 reports
- Bard® X-Force® Balloon Dilation Catheter 998606DILATOR, CATHETER, URETERAL27 reports
- Bard® X-Force® Balloon Dilation Catheter 998006DILATOR, CATHETER, URETERAL25 reports
- Bard® X-Force® Balloon Dilation Catheter 998806DILATOR, CATHETER, URETERAL23 reports
- Bard® X-Force® Balloon Dilation Catheter 998504DILATOR, CATHETER, URETERAL16 reports
- Bard® X-Force® Balloon Dilation Catheter 998506DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998004DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998804DILATOR, CATHETER, URETERAL12 reports
- Bard® X-Force® Balloon Dilation Catheter 997606DILATOR, CATHETER, URETERAL11 reports
- Bard® X-Force® Balloon Dilation Catheter 998404DILATOR, CATHETER, URETERAL11 reports
- Bard® X-Force® Balloon Dilation Catheter 997706DILATOR, CATHETER, URETERAL7 reports
- Bard® X-Force® Balloon Dilation Catheter 998010DILATOR, CATHETER, URETERAL7 reports
- Bard® X-Force® Balloon Dilation Catheter 998406DILATOR, CATHETER, URETERAL6 reports
- Bard® X-Force® Balloon Dilation Catheter 998604DILATOR, CATHETER, URETERAL4 reports
- Bard® X-Force® Balloon Dilation Catheter 997710DILATOR, CATHETER, URETERAL3 reports
- Bard® X-Force® Balloon Dilation Catheter 998610DILATOR, CATHETER, URETERAL3 reports
- Bard® X-Force® Balloon Dilation Catheter 997610DILATOR, CATHETER, URETERAL2 reports
- Bard® X-Force® Balloon Dilation Catheter 998810DILATOR, CATHETER, URETERAL2 reports
- Bard® X-Force® Balloon Dilation Catheter 997504DILATOR, CATHETER, URETERAL1 report
- Bard® X-Force® Balloon Dilation Catheter 997604DILATOR, CATHETER, URETERAL1 report
- Bard® X-Force® Balloon Dilation Catheter 997006DILATOR, CATHETER, URETERAL1 report
- Bard® X-Force® Balloon Dilation Catheter 998510DILATOR, CATHETER, URETERAL1 report
Recent Bard X-Force 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.
MalfunctionSep 30, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951852 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781988 ↗MalfunctionSep 11, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741622 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452739 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452738 ↗InjuryJun 17, 2026Material Fragmentation
IT WAS REPORTED THAT A PATIENT WHO HAD A STENT PLACED AT OUR FACILITY AND WAS MANAGED AT ANOTHER FACILITY FOR APPROXIMATELY ONE YEAR PRESENTED TO OUR HOSPITAL WITH URINARY RETENTION. WHILE IT WAS POSSIBLE THAT THE STENT REMAINS INSIDE THE BODY, DETAILS CANNOT BE DETERMINED UNTIL THE URINARY RETENTION IS RESOLVED VIA A NEPHROSTOMY APPROACH. THEREFORE, THEY ARE REQUESTING INFORMATION ON WHETHER THERE HAVE BEEN ANY CASES IN THE PAST WHERE A STENT BROKE AND REMAINED INSIDE THE BODY AFTER ONE YEAR OF PLACEMENT. POSSIBILITY OF URINARY TRACT OBSTRUCTION DURING URETERAL STENT PLACEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient
MAUDE report 25537328 ↗MalfunctionApr 28, 2026Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT DURING THE SECOND DILATION ON THE SAME PROCEDURE, THE BALLOON DILATION CATHETER PRESSURE PUMP SHOWED THAT IT COULD NOT REACH THE SPECIFIED PRESSURE. A LEAK WAS FOUND, AND AFTER REPLACING THE BALLOON, THE DILATION WAS SUCCESSFULLY COMPLETED. THE USER WAS EXPOSED TO BODILY FLUID.
Patient problems: Exposure to Body Fluids
MAUDE report 25019148 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708808 ↗MalfunctionDec 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708792 ↗MalfunctionDec 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708791 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON DILATION CATHETER BALLOON WAS OPENED AND FOUND TO BE DAMAGED, WITH THE PRESSURE PUMP LEAKING. THEY REPLACED WITH A NEW BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708519 ↗MalfunctionNov 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT AFTER OPENING THE BALLOON DILATION CATHETER PACKAGE, THE LOWER PART OF THE BALLOON HEAD WAS FOUND TO BE OBVIOUSLY DAMAGED. REPLACED WITH A NEW BALLOON FOR THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23524035 ↗MalfunctionOct 24, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING SURGERY, CONTRAST MEDIUM LEAKED FROM THE BALLOON DILATION CATHETER BALLOON DURING THE THIRD BALLOON DILATION. PER ADDITIONAL INFORMATION RECEIVED VIA TASK ON 30OCT2025, STATED THAT CONTRAST AGENT LEAKED FROM THE BALLOON PART DURING THE THIRD BALLOON DILATION. THE CONTRAST AGENT LEAKAGE COULD NOT BE CONFIRMED UNTIL THE SECOND DILATION, THE CONTRAST AGENT LEAKED OUT FOR THE THIRD TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382269 ↗MalfunctionSep 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT, AIR COULD NOT BE INJECTED AS THE BALLOON DID NOT INFLATE OF THE BALLOON DILATION CATHETER. BALLON TEAR WAS FOUND. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12OCT2025, STATED THAT NO MEDICAL INTERVENTION WAS INVOLVED AND THERE WAS NO COURSE OF TREATMENT CHANGED DUE TO EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23133558 ↗MalfunctionSep 17, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THERE WAS DIFFICULTY IN DRAINING STERILIZED WATER FROM THE FOLEY CATHETER DURING PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073649 ↗
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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