Bard® X-Force® Balloon Dilation Catheter 998406Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801741052658), received between Apr 25, 2017 and May 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN PRESSURE WAS APPLIED DURING DILATION, THERE WAS A STRANGE SENSATION, SO THEY REMOVED THE DEVICE AND CHECKED IT, AND FOUND THAT STERILE WATER HAD LEAKED FROM THE BALLOON DILATION CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088956 ↗
• MalfunctionJan 11, 2023Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE FOLEY CATHETER SHAFT (YELLOW-GREEN PART) DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137338 ↗
• MalfunctionDec 19, 2019Use of Device Problem; Use of Device Problem; Pressure Problem

  IT WAS REPORTED THAT THE BALLOON INFLATED, THE PRESSURE WAS RAISED, BUT THE PRESSURE ON THE EAGLE INFLATION DEVICE DID NOT GO UP.

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

  MAUDE report 9499161 ↗
• MalfunctionOct 16, 2019Leak/Splash; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PRESSURE LEAK OCCURRED AT THE INFLATION DEVICE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL ON (B)(6) 2019, IT WAS UNKNOWN IF THE DILATION BALLOON WAS ABLE TO BE INFLATED OR IF THE USER WAS ABLE TO FEEL THE LEAK FROM THE INFLATION DEVICE.

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

  MAUDE report 9197439 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN THE USER APPLIED PRESSURE, THERE WAS A SMALL SOUND FROM THE METER AND WATER LEAKED.

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

  MAUDE report 7888691 ↗
• MalfunctionApr 25, 2017Break; Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON AS THE CONTRAST MEDIUM WAS INJECTED INTO THE INFLATION DEVICE. THE BALLOON SHAPE WAS UNUSUAL. THE DEVICE WAS REMOVED FROM THE PATIENT. AFTER FURTHER INSPECTION, IT WAS FOUND THAT THE SHAFT OF THE CATHETER WAS DAMAGED PREVENTING THE BALLOON TO INFLATE IN ITS REGULAR SHAPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6519281 ↗