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Bard® X-Force® Balloon Dilation Catheter 997504Recalls & 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 00801741052064), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • MalfunctionMar 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT WHEN THE CONTRAST WAS INJECTED, DOCTOR FOUND THAT THE CONTRAST WAS POURING OUT OF THE BALLOON. WHEN THE FOLEY CATHETER WAS REMOVED, IT WAS FOUND THAT THE SHEATH HAD TORN. PER INFORMATION RECEIVED THE PATIENT DID NOT GOT INJURED.

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

    MAUDE report 11435729 ↗

Other DILATOR, CATHETER, URETERAL devices

All DILATOR, CATHETER, URETERAL devices →

Sources and updates

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