Bard® X-Force® Balloon Dilation Catheter 998010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801741052818), received between Apr 26, 2017 and May 30, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRESSURE DID NOT RISE TO 30 ATMOSPHERES. THEY INFLATED THE BALLOON AT 20 TO 25 ATM FOR THE FIRST TIME WITHOUT FILLING THE SYRINGE WITH A CONTRAST MEDIUM TO IT WAS MAXIMUM CAPACITY. AFTERWARD, THE BALLOON WAS REMOVED BEFORE ALL THE CONTRAST MEDIUM WAS REMOVED. THEY MOVED THE POSITION AND TRIED TO RAISE THE PRESSURE TO 30 ATM, BUT IT WOULD NOT RISE, SO WHEN THEY TRIED TO FORCE IT UP TO 30 ATM, THE SURGEON SAID IT FELT LIKE THE BALLOON HAD BURST. IT WAS UNCLEAR WHETHER THERE WAS A STONE IN THE URETHRA THAT CAUSED THE INJURY, OR WHETHER THE PROCEDURE DESCRIBED ABOVE CAUSED THE BALLOON TO BE TOO FORCEFUL AND CAUSE INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19423911 ↗
• InjurySep 19, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS URETERAL DAMAGE. AFTER URETERAL DILATION, A URETERAL BALLOON DILATION CATHETER WAS INSERTED OVER THE GUIDEWIRE. ANGIOGRAPHY WAS PERFORMED WHILE PULLING THE URETERAL CATHETER FROM THE URETEROPELVIC JUNCTION TO THE URETEROVESICAL JUNCTION. AFTER ANGIOGRAPHY, A GUIDEWIRE WAS ATTEMPTED THROUGH THE URETERAL CATHETER LUMEN, BUT THERE WAS RESISTANCE FROM THE URETEROVESICAL JUNCTION AREA, AND INSERTION WAS DIFFICULT. WHEN ANGIOGRAPHY WAS PERFORMED AGAIN, CONTRAST MATERIAL WAS LEAKING FROM THE UPPER PART OF THE URETEROVESICAL JUNCTION, CONFIRMING URETERAL PERFORATION. DUE TO DIFFICULTY PASSING THE GUIDEWIRE, THE URETERAL STENT COULD NOT BE PLACED AND TERMINATED. LATER, A NEPHROSTOMY WAS PERFORMED, AND AN ANTEGRADE APPROACH WAS SCHEDULED.

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

  MAUDE report 17772509 ↗
• MalfunctionJan 26, 2021Inflation Problem; Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER DID NOT INFLATE WHEN THE PRESSURE APPLIED FROM THE INFLATION DEVICE TO DILATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11229145 ↗
• MalfunctionJul 3, 2020Inflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO INFLATE DURING PRETEST.

  Patient problems: No Patient Involvement

  MAUDE report 10227797 ↗
• MalfunctionOct 15, 2019Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE CATHETER BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9192330 ↗
• MalfunctionSep 26, 2018Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT WATER LEAKAGE OCCURRED FROM THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7910019 ↗
• MalfunctionApr 26, 2017Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE AFTER THE CATHETER WAS INSERTED INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6522927 ↗