ULTRASCORE US35130412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741116681), received between Nov 13, 2018 and Jun 26, 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.

• 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 8737700 ↗
• InjuryJun 25, 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 ARTERY WITH A FOCUSED FORCED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, FOLLOWING USE OF THE STUDY DEVICE, DISSECTION WAS IDENTIFIED. THE TARGET LESION WAS TREATED WITH DRUG-COATED BALLOON ANGIOPLASTY FOLLOWED BY STENT PLACEMENT.

  Patient problems: Reocclusion; Vascular Dissection

  MAUDE report 8731578 ↗
• InjuryNov 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 POPLITEAL ARTERY WITH A FOCUSED FORCED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, FOLLOWING USE OF THE STUDY DEVICE, A FISTULA OF THE POPLITEAL ARTERY WAS IDENTIFIED. THE TARGET LESION WAS TREATED WITH DRUG-COATED BALLOON ANGIOPLASTY FOLLOWED BY STENT PLACEMENT. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Fistula; Vascular Dissection

  MAUDE report 8066821 ↗