ULTRASCORE US141503H30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741113659), received between Jul 24, 2020 and Jul 24, 2020 — 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

Recent adverse event reports

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

• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY TRIAL, A FOCUSED FORCE PTA BALLOON WAS USED TO TREAT THE LEFT FEMORAL ARTERY AND DISSECTION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT APPROXIMATELY 6-MONTH POST INDEX PROCEDURE, OCCLUSION WAS IDENTIFIED VIA DUPLEX ULTRASOUND. IT WAS FURTHER REPORTED THAT THE MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENTS. THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

  Patient problems: Occlusion; Vascular Dissection

  MAUDE report 10322302 ↗