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ULTRASCORE US3513048Recalls & reported problems

Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 4mm x 80mm, 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741116667), received between Aug 29, 2023 and Aug 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Device problems

  • Difficult to Remove1
  • Material Deformation1

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.

  • MalfunctionAug 29, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY GOT STUCK IN THE SHEATH AFTER INFLATION AND RETRACTION. IT WAS FURTHER REPORTED THAT THE SCORING WIRE OF THE PTA BALLOON ALLEGEDLY DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17641367 ↗

Other Catheter, percutaneous, cutting/scoring devices

All Catheter, percutaneous, cutting/scoring devices →

Sources and updates

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