ULTRASCORE US35130620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741116902), received between Dec 21, 2018 and Nov 14, 2019 — classified as 3 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 16, 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.

• InjuryNov 14, 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 STUDY TRIAL, A FOCUSED FORCE PTA BALLOON WAS USED TO TREAT THE RIGHT FEMORAL ARTERY AND DISSECTION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT APPROXIMATELY 6-MONTH POST INDEX PROCEDURE, STENOSIS WAS IDENTIFIED VIA DUPLEX ULTRASOUND. NO TREATMENT HAS BEEN PROVIDED AT THIS MOMENT.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 9324309 ↗
• InjurySep 4, 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 AFTER ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER DUPLEX ULTRASOUND DEMONSTRATED DISSECTION TYPE D AND STENT WAS PLACED. APPROXIMATELY SIX MONTHS AND TWELVE MONTHS POST INDEX PROCEDURE, DUPLEX ULTRASOUND WAS PERFORMED AND STENOSIS WAS IDENTIFIED. THE SUBJECT COMPLETED THE STUDY.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8961777 ↗
• InjuryDec 21, 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, VESSEL DISSECTION WAS IDENTIFIED AFTER TWO INFLATIONS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A BARE METAL 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 8189663 ↗