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ULTRASCORE US3513088Recalls & reported problems

Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 8mm x 80mm, 130cm catheter · Class 2

All models of ULTRASCORE (61)

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 00801741117077), received between Oct 21, 2020 and Oct 21, 2020 — 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

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.

  • MalfunctionOct 21, 2020Break; Break

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, ALLEGEDLY CATHETER TIP WAS TORN OFF. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10711368 ↗

Other Catheter, percutaneous, cutting/scoring devices

All Catheter, percutaneous, cutting/scoring devices →

Sources and updates

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