Bard® X-Force® Balloon Dilation Catheter 998610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741052726), received between Aug 17, 2018 and Oct 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE AIR AND WATER LEAKED FROM THE YELLOW GREEN SHAFT AREA OF BALLOON DILATION CATHETER AND WAS UNABLE TO APPLY PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605308 ↗
• MalfunctionOct 6, 2021Burst Container or Vessel; Gas/Air Leak; Burst Container or Vessel; Gas/Air Leak

  IT WAS REPORTED THAT AIR AND WATER LEAKED FROM THE YELLOW GREEN SHAFT AREA OF BALLOON DILATION CATHETER AND WAS UNABLE TO APPLY PRESSURE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 07MAR2022, IT WAS CONFIRMED THAT BASED ON SAMPLE EVALUATION PERFORMED BY THE SUPPLIER, THERE WAS A BURST IN THE SHAFT OF THE BALLOON DILATION CATHETER WHICH RESULTED IN THE AIR AND WATER LEAKAGE. THE AIR AND WATER LEAK CASCADES WITH THE BURST IN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583115 ↗
• MalfunctionAug 17, 2018Inflation Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE PHYSICIAN USED THE INFLATION DEVICE, BUT THE PRESSURE DID NOT INCREASE.

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

  MAUDE report 7793830 ↗