ULTRASCORE US35130612Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741116889), received between Dec 13, 2018 and Jul 22, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Leak/Splash; Material Puncture/Hole; Material Split, Cut or Torn; Leak/Splash; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT ALLEGEDLY HAD HOLE. IT WAS FURTHER REPORTED THAT THE CONTRAST SOLUTION CAME OUT OF THE SHAFT OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19789993 ↗
• InjuryJun 26, 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 IN THE SUPERIAL FEMORAL ARTERY AND POPLITEAL WITH A FOCUSED FORCED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, FOLLOWING USE OF THE STUDY DEVICE, DISSECTION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT STENT WAS PLACED IN SFA. PATIENT WAS DISCHARGED FROM HOSPITAL SAME DAY. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULT OF A CLINICAL TRIAL APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, PATIENT EXPERIENCED STENOSIS.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8737658 ↗
• InjuryDec 13, 2018Adverse 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 IN THE LEFT MID/DISTAL SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, IMAGING DEMONSTRATED DISSECTION WHICH RESULTED IN STENT PLACEMENT. FOLLOWING STENT PLACEMENT, IMAGING NO LONGER DEMONSTRATE THE DISSECTION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 8161617 ↗