ULTRASCORE US141502H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741113437), received between Sep 24, 2020 and Nov 3, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 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 APPROXIMATELY THREE MONTHS AND TEN DAYS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION AND VESSEL STENOSIS. ATHERECTOMY WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 10776992 ↗
• InjurySep 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 TRIAL THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, VESSEL OCCLUSION OCCURRED BETWEEN RULER MARKER 9-10 CM. THE TARGET LESION OCCLUSION WAS TREATED WITH STANDARD PTA. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Occlusion

  MAUDE report 10579015 ↗