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Bard® X-Force® Balloon Dilation Catheter 997604Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741052095), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 malfunction.

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

Device problems

  • Break1
  • Device Damaged Prior to Use1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 15, 2019Break; Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED THAT AFTER BREAKING THE PACKAGE, THE PUTTER WAS FOUND TO BE DAMAGED. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC,THAT THE PACKAGE WAS NOT BROKEN. THE PUTTER WAS DAMAGED WHEN THE PACKAGE WAS OPENED. THE TYPE OF DAMAGE IS CURRENTLY UNKNOWN.

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

    MAUDE report 8515794 ↗

Other DILATOR, CATHETER, URETERAL devices

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Sources and updates

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