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UroForce® Balloon Dilation Catheter 887410Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741052962), received between Jun 6, 2023 and Jun 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequate or Insufficient Training” (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

  • Inadequate or Insufficient Training1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 6, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

    IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THEY WERE NOT ABLE TO SUCCESSFULLY SUSTAIN AND/OR MONITOR PRESSURE WITH THE EAGLE INFLATION DEVICE. STATED THAT THE UROFORCE BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE WAS NOT SUCCESSFUL IN SUSTAINING AND/OR MONITORING PRESSURE BECAUSE OF LACK OF NURSING STAFF EXPERIENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17069888 ↗

Other DILATOR, CATHETER, URETERAL devices

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Sources and updates

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