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ULTRASCORE US35130415Recalls & reported problems

Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 4mm x 150mm, 130cm catheter · Class 2

All models of ULTRASCORE (61)

Data updated Oct 16, 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 00801741116698), received between Mar 4, 2019 and Mar 4, 2019 — 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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS FURTHER REPORTED A BARE METAL STENT WAS PLACED AT THE TARGETED LESION. PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE.

    Patient problems: Vascular Dissection

    MAUDE report 8387627 ↗

Other Catheter, percutaneous, cutting/scoring devices

All Catheter, percutaneous, cutting/scoring devices →

Sources and updates

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