Bard® X-Force® Balloon Dilation Catheter 997006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741052194), received between May 22, 2023 and May 22, 2023 — classified as 1 injury.

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

• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PEDIATRIC PATIENT (14 YEARS OLD) EXPERIENCED PERFORATION AND URINARY TRACT INFECTION AFTER PLACEMENT OF THE DEVICE, THESE COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO USAGE OF BALLOON DILATION CATHETER. PERFORATION WAS NOT PRESENT PRIOR TO PLACEMENT OF THE DEVICE AND DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. URINARY TRACT INFECTION WAS PRESENT PRIOR TO PLACEMENT OF THE DEVICE, AND DID RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION SUCH AS URETERAL SCARRING. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Perforation; Urinary Tract Infection

  MAUDE report 16973274 ↗