ULTRASCORE US35130615Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741116896), received between Oct 16, 2018 and Feb 1, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2021Adverse 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, FINAL MORPHOLOGY IMAGING DEMONSTRATED GRADE D DISSECTION. THE SUBJECT COMPLETED THE STUDY.

  Patient problems: Vascular Dissection

  MAUDE report 11259025 ↗
• InjuryOct 31, 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 DURING ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, DISSECTION TYPE B WAS IDENTIFIED AND A STENT WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Vascular Dissection

  MAUDE report 9263457 ↗
• InjuryDec 27, 2018Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; 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 AFTER TWO INFLATIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT. THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT WAS DISCHARGED THE SAME DAY AS THE INDEX PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8200875 ↗
• InjuryOct 16, 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 WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, AFTER SIX INFLATION IN THE SUPERFICIAL FEMORAL ARTERY, A DISSECTION WAS IDENTIFIED. REPORTEDLY, PTA AND BARE METAL STENTING WERE PERFORMED. THE EVENT WAS CONSIDERED TO BE RESOLVED AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7972365 ↗