ULTRASCORE US14150320Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741113536), received between Dec 3, 2019 and Aug 19, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 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, GRADE E DISSECTION OCCURRED AFTER USE OF THE STUDY DEVICE AND A STENT WAS PLACED. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 10425191 ↗
• InjuryJun 29, 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 APPROXIMATELY 6-MONTH POST INDEX PROCEDURE, THE PATIENT EXPERIENCED 100% STENOSIS AND REVASCULARIZATION WAS PERFORMED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 10210164 ↗
• MalfunctionJan 14, 2020Break; Deflation Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Deflation Problem; Detachment of Device or Device Component; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150320 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A 72-YEAR-OLD MALE WEIGHING 90 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587609 ↗
• InjuryJan 7, 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 STUDY TRIAL, A FOCUSED FORCE PTA BALLOON WAS USED TO TREAT THE LEFT FEMORAL ARTERY, THE PATIENT EXPERIENCED STENOSIS OF TARGET LESION AND APPROXIMATELY 6-MONTH AND 26 DAYS REVASCULARIZATION WAS PERFORMED.

  Patient problems: Stenosis

  MAUDE report 9560732 ↗
• InjuryDec 3, 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 APPROXIMATELY 4-MONTH POST INDEX PROCEDURE, PATIENT HAD TARGET LESION REVASCULARIZATION WITH ANGIOPLASTY AND CUTTING /SCORING BALLOON .

  Patient problems: Stenosis

  MAUDE report 9401705 ↗