Bard® X-Force® Balloon Dilation Catheter 997706Recalls & reported problems
C. R. Bard, Inc. · Bard® X-Force® Balloon Dilation Catheter · Class 2
All models of Bard X-Force Balloon Dilation Catheter (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741052132), received between Apr 22, 2022 and Sep 24, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Burst Container or Vessel1
- Gas/Air Leak1
- Material Rupture1
- Material Split, Cut or Torn1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY AND LITHOTRIPSY PROCEDURE ON (B)(6) 2024, THE PRESSURE GAUGE DID NOT SHOW UP DURING THE ASSISTANT'S PRESSURIZATION PROCESS, AND UPON REMOVAL, TESTING REVEALED THAT THE BALLOON DILATION CATHETER HAD A TEAR THAT PREVENTED IT FROM EXPANDING EFFICIENTLY, AND IT WAS REPLACED WITH A NEW PRODUCT FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000092 ↗MalfunctionMay 15, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE URETERAL DILATION BALLOON WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16933669 ↗MalfunctionMay 9, 2023Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE MEDICAL STAFF PERFORMED SURGERY ON THE PATIENT ON (B)(6) 2023. DURING THE OPERATION, IT WAS FOUND THAT THE FRONT END OF THE BALLOON DILATATION CATHETER WAS BLOCKED AND THE OPERATION COULD NOT BE PERFORMED. THEN, A NEW DEVICE WAS REPLACED IMMEDIATELY. THE OPERATION WENT SMOOTHLY AND WAS REPORTED TO THE MEDICAL EQUIPMENT DEPARTMENT. IT DID NOT CAUSE SIGNIFICANT HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894624 ↗MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCESS OF INFLATION, LEAKAGE OCCURRED AT THE BALLOON OF THE URETERAL DILATION BALLOON CATHETER AND THE USER REPLACED IT WITH A NEW CATHETER. IT WAS MENTIONED THAT AN EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT. AS PER THE FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, IT WAS STATED THAT THE EVENT INCLUDED EXTRA OPERATION OR DRUG THERAPY REFERS TO THE CATHETER REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189599 ↗InjuryApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LEAK OCCURRED FROM THE BALLOON DILATION CATHETER DURING THE PROCESS OF INFLATION AND THEN REPLACED WITH A NEW DEVICE. IT WAS MENTIONED THAT THE EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14189483 ↗InjuryApr 22, 2022Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak
IT WAS REPORTED THAT THE LEAK HAD OCCURRED AT THE CONNECTING BETWEEN THE END OF BALLOON CATHETER AND PRESSURE PUMP DURING THE PROCESS OF INFLATION AND THEN REPLACED WITH A NEW DEVICE. IT WAS MENTIONED THAT AN EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT. AS PER THE FOLLOW-UP RECEIVED ON 07APR2022. THERE WAS NO SAMPLE AVAILABLE AND A NEW CATHETER WAS REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14189476 ↗
Other DILATOR, CATHETER, URETERAL devices
- Porges Coloplast RBD014Coloplast A/S · DILATOR, CATHETER, URETERAL1 recall0 reports
- Bard® X-Force® Balloon Dilation Catheter 998706C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL38 reports
- Bard® X-Force® Balloon Dilation Catheter 998606C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL27 reports
- Bard® X-Force® Balloon Dilation Catheter 998006C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL25 reports
- Bard® X-Force® Balloon Dilation Catheter 998806C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL23 reports
- Bard® X-Force® Balloon Dilation Catheter 998504C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL16 reports
- Bard® X-Force® Balloon Dilation Catheter 998004C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998506C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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