ULTRASCORE US141503H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741113635), received between Jan 15, 2020 and Jan 15, 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.

• InjuryJan 15, 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 TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED IN THE PEDAL ARTERY. IT WAS FURTHER REPORTED THERE WAS NO MEDICAL INTERVENTION PERFORMED. PATIENT WAS DISCHARGED THE SAME DAY AS THE PROCEDURE. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY 1-MONTH AND 26 DAYS POST ANGIOPLASTY PROCEDURE, STENOSIS WAS IDENTIFIED IN THE PEDAL ARTERY. IT WAS FURTHER REPORTED REVASCULARIZATION WAS PERFORMED USING PTA (NON DCB).

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 9592093 ↗