Bard X-Force Nephrostomy Balloon Dilation CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 4 models of Bard X-Force Nephrostomy Balloon Dilation Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2017 and Sep 25, 2026 — classified as 5 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (21 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 Nephrostomy Balloon Dilation Catheter problems
Device problems
- Burst Container or Vessel21
- Inflation Problem12
- Material Fragmentation6
- Material Puncture/Hole6
- Fluid/Blood Leak5
- Material Rupture5
- Break4
- Nonstandard Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Known Impact Or Consequence To Patient16
- No Consequences Or Impact To Patient15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Patient Involvement4
- No Information3
- Hemorrhage/Blood Loss/Bleeding2
- Perforation2
Bard X-Force Nephrostomy Balloon Dilation Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter 996101CATHETER, NEPHROSTOMY24 reports
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter 995081CATHETER, NEPHROSTOMY21 reports
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter 996081CATHETER, NEPHROSTOMY19 reports
- Bard® X-Force® Nephrostomy Balloon Dilation Catheter 995101CATHETER, NEPHROSTOMY9 reports
Recent Bard X-Force Nephrostomy 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 25, 2026Material Puncture/Hole
It was reported that during the procedure prior to use, leakage was detected at the tip of the balloon, preventing it from expanding to the specified pressure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899367 ↗MalfunctionSep 16, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796647 ↗MalfunctionSep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791409 ↗MalfunctionJun 11, 2026Material Rupture
IT WAS REPORTED THAT DURING USE INFLATOR RUPTURED. AFTER DRAWING CONTRAST AGENT INTO THE EAGLE INFLATOR AND CONNECTING IT TO THE X FORCE CATHETER, USER MANUALLY PUSHED THE PLUNGER. WHEN THE PRESSURE GAUGE DISPLAYED 7 TO 8 ATM, THERE WAS A LOUD SOUND OF RUPTURE, AND CONTRAST AGENT SPRAYED OUT FROM THE AREA NEAR, VICINITY OF, THE BLACK PLASTIC DIRECTLY BELOW THE MANOMETER. CONTRAST AGENT SPLASHED ONTO FACE. THE CONTRAST AGENT ONLY GOT ON FACE AND DIDN'T CAUSE SERIOUS HARM. THERE WERE NO HEALTH HAZARDS OR ALLOWANCES FOR THE PRACTITIONERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480172 ↗MalfunctionFeb 4, 2026Material Puncture/Hole
IT WAS REPORTED THAT A PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED. THE PACKAGING OF THE NEPHROSTOMY BALLOON DILATATION CATHETER WAS NOT DAMAGED UPON OPENING. AFTER PLACING THE GUIDEWIRE AND POSITIONING THE BALLOON, SALINE WAS INJECTED BUT THE BALLOON FAILED TO INFLATE AND ESTABLISH A PATHWAY. IT WAS DISCOVERED THAT A TEAR AT THE BALLOON TIP CAUSED LEAKAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264631 ↗MalfunctionDec 9, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE CUSTOMER ORDERED 2 BOXES REF: (B)(4), LOT: BMKZFM16, CUSTOMER NORMALLY RECEIVES A GREEN BOX, HOWEVER THEY RECEIVED A BLUE BOX WITH THE SAME MATERIAL AND LOT NUMBER LISTED ON IT. THE GREEN BOX HAS THE PTA SHEET IN IT, WHILE THE BLUE BOX RECEIVED, HAS PICTURES SHOWING THE SHEET WAS SUPPOSED TO BE IN IT. HOWEVER, THEY WERE NO SHEETS CONTAINED IN THE TWO BOXES. CUSTOMER WOULD LIKE SOMEONE REACH OUT TO THEM AS SOON AS POSSIBLE AS THEY HAD AN UPCOMING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764877 ↗MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PRIOR TO PERFORMING URETERAL STRICTURE DILATION SURGERY, WHEN OPENING THE URETERAL STRICTURE BALLOON FOR USE, A NOTICEABLE LEAK WAS OBSERVED IN THE PRESSURE PUMP. REPLACED THE BALLOON SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485367 ↗MalfunctionSep 18, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER BALLOON, HEALTH PROFESSIONALS TRIED TO EXPAND IT BUT IT DID NOT INFLATE, CHECKED AND FOUND THAT CONTRAST MEDIUM WAS LEAKING FROM THE CONNECTION BETWEEN THE INFLATION LUMEN AND THE PRESSURIZER. REPLACED THE CATHETER AND COMPLETED THE PROCEDURE WITHOUT ANY PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084161 ↗MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT BEFORE USE, THE SHEATH IN GREEN PORTION OF THE BALLOON DILATION CATHETER WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458578 ↗MalfunctionJul 9, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT BEFORE USE, PHYSICIANS ATTEMPTED SEVERAL TIMES TO BALLOONING THE BALLOON DILATION CATHETER, BUT IT WAS UNSUCCESSFUL. BALLOON DID NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458426 ↗MalfunctionApr 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING USE, BALLOON DILATION CATHETER BALLOON DEFLATED. AN ISSUE THEY ENCOUNTERED WITH ONE OF NEPHROSTOMY BALLOON DILATION CATHETER BALLOONS DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. AFTER FULL INFLATION, THEY OBSERVED A GRADUAL DECREASE IN PRESSURE, AND UPON FURTHER INSPECTION, THEY DISCOVERED A HOLE IN THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21813678 ↗MalfunctionApr 9, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE PRESSURE DID NOT REACH THE LEVEL AS IT WAS LOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21806431 ↗MalfunctionSep 23, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING THE ERICS PROCEDURE THE BALLOON DILATION CATHETER FAILED TO INFLATE PROPERLY BECAUSE CONTRAST LIQUID LEAKAGE FROM THE MANOMETER DURING FLUID INSUFFLATION. (BATCH#BMGWAT01, BATCH#BMGYFM44). PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 09SEP2024, CUSTOMER CONFORMED, EVENT DURING USE AND NEED TO CHANGE PERCUTANEOUS DILATATION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278868 ↗MalfunctionAug 8, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation
IT WAS REPORTED THAT THE SPECIALIST WAS PERFORMED A PCNL PROCEDURE, THAT REQUIRED THE USE OF A BALLOON DILATATION CATHETER, WHILE THE BALLOON WAS INJECTED WITH WATER WITH THE BD PRESSURE PUMP, THE PRESSURE PUMP BURST AND WAS UNABLE TO CONTINUE, AND THE PROCEDURE WAS CONTINUED AFTER REPLACING THE P UMP WITH A NEW ONE, WHICH DELAYED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19940113 ↗MalfunctionFeb 6, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE BALLOON DILATION CATHETER CONNECTOR TO THE PRESSURE GUN COULD NOT BE LOCKED. AFTER REPLACING IT WITH A NEW SET OF DILATION CATHETERS, IT COULD BE LOCKED AND OPERATED NORMALLY WITH THE SAME PRESSURE GUN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18650061 ↗
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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