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UroForce® Balloon Dilation Catheter 887406Recalls & reported problems

C. R. Bard, Inc. · UroForce® Balloon Dilation Catheter · Class 2

All models of UroForce Balloon Dilation Catheter (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741052955), received between May 18, 2023 and May 18, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Urinary Tract Infection1

Recent adverse event reports

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

  • InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED VIA SURVEY RESPONSE THAT A MALE PEDIATRIC PATIENT (13 YEARS OLD) EXPERIENCED URINARY TRACT INFECTION AFTER PLACEMENT OF THE DEVICE, THIS COMPLICATION WAS DIRECTLY ATTRIBUTABLE TO USAGE OF BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE. URINARY TRACT INFECTION WAS PRESENT PRIOR TO PLACEMENT OF THE DEVICE, AND DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. MEDICAL INTERVENTION WAS UNKNOWN.

    Patient problems: Urinary Tract Infection

    MAUDE report 16953402 ↗

Other DILATOR, CATHETER, URETERAL devices

All DILATOR, CATHETER, URETERAL devices →

Sources and updates

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