Bard® X-Force® Balloon Dilation Catheter 998404Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10801741052641), received between May 2, 2017 and Jun 17, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Material Fragmentation

  IT WAS REPORTED THAT A PATIENT WHO HAD A STENT PLACED AT OUR FACILITY AND WAS MANAGED AT ANOTHER FACILITY FOR APPROXIMATELY ONE YEAR PRESENTED TO OUR HOSPITAL WITH URINARY RETENTION. WHILE IT WAS POSSIBLE THAT THE STENT REMAINS INSIDE THE BODY, DETAILS CANNOT BE DETERMINED UNTIL THE URINARY RETENTION IS RESOLVED VIA A NEPHROSTOMY APPROACH. THEREFORE, THEY ARE REQUESTING INFORMATION ON WHETHER THERE HAVE BEEN ANY CASES IN THE PAST WHERE A STENT BROKE AND REMAINED INSIDE THE BODY AFTER ONE YEAR OF PLACEMENT. POSSIBILITY OF URINARY TRACT OBSTRUCTION DURING URETERAL STENT PLACEMENT.

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

  MAUDE report 25537328 ↗
• MalfunctionFeb 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON PART OF THE BALLOON DILATION CATHETER WAS DAMAGED. THE BALLOON DID NOT INFLATE WHEN USED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 25JAN2025, STATED THAT THE DAMAGE TO THE BALLOON COULD NOT BE CONFIRMED BY VISUAL INSPECTION. THE BALLOON HAD NOT BURST. IT SEEMS TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354577 ↗
• MalfunctionAug 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CONNECTION TO THE EAGLE INFLATION DEVICE WAS CRACKED, AND THE BALLOON COULD NOT BE EXPANDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480091 ↗
• MalfunctionFeb 8, 2023Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED THAT THE SHAFT BELOW THE BALLOON GOT BROKEN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317930 ↗
• MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONTRAST AGENT LEAKED FROM THE BASE OF THE CATHETER BALLOON AND THE BALLOON WAS UNABLE TO BE DILATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11089819 ↗
• MalfunctionSep 25, 2020Break; Leak/Splash; Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE CATHETER LEAKED THE WATER BECAUSE THE INFLATION DEVICE WAS BROKEN BEFORE THE USE.

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

  MAUDE report 10586886 ↗
• MalfunctionApr 11, 2019Crack; Inflation Problem; Pressure Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRESSURE DID NOT RISE AFTER THE CATHETER INSERTION. FOLLOWING REMOVAL, A CRACK WAS FOUND ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

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

  MAUDE report 8504736 ↗
• MalfunctionApr 11, 2019Break; Crack; Pressure Problem; Break

  IT WAS REPORTED THAT THE PRESSURE DID NOT RISE AFTER THE CATHETER WAS INSERTED. FOLLOWING REMOVAL, A CRACK WAS FOUND ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

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

  MAUDE report 8503256 ↗
• MalfunctionNov 24, 2017Inflation Problem

  IT WAS REPORTED THAT THE INFLATION DEVICE DID NOT MOVE DURING USAGE. THE INFLATION DEVICE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7057740 ↗
• MalfunctionMay 19, 2017Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE SHAFT OF THE CATHETER HAD RUPTURED AS THE USER ATTEMPTED PRESSURE WITH THE INFLATION DEVICE. THE USER INSERTED THE CATHETER INTO THE STRUCTURE AREA OF THE URETERAL, AND ATTEMPTED PRESSURE WITH THE INFLATION DEVICE, BUT THE BALLOON OF THE CATHETER COULD NOT BE INFLATED AND THE METER DID NOT INDICATE APPLIED PRESSURE. THE USER FOUND THAT THE SHAFT OF THE CATHETER HAD RUPTURED, THEN THE CATHETER WAS REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578670 ↗
• MalfunctionMay 2, 2017Break

  IT WAS REPORTED THAT THE JUNCTION PART OF THE SHAFT, WHICH WAS ON THE FRONT SIDE OF THE BIFURCATION AREA, WAS BROKEN AS THE USER ATTEMPTED TO DILATE THE URETER WITH THE URETER CATHETER BY APPLYING 27 DIASTOLIC PRESSURE. ANOTHER OF THE SAME TYPE OF DEVICE WAS USED, AND THE TREATMENT WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6538814 ↗