ULTRASCORE US3513064Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741116841), received between Nov 9, 2020 and Apr 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionApr 30, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ULTRASCORE 035 PTA BALLOON. DURING THE PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY COULD NOT BE REMOVED FROM SHEATH. IT WAS FURTHER REPORTED THAT THE WIRE ATTACHED TO THE BALLOON WAS BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934499 ↗
• MalfunctionJan 26, 2023Backflow; Break; Crack; Leak/Splash; Material Rupture; Deformation Due to Compressive Stress; Backflow; Break; Crack; Leak/Splash; Material Rupture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY LEAKED NEAR Y-PIECE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY TORN FROM THE SHAFT AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245252 ↗
• InjuryNov 9, 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, IMAGING DEMONSTRATED GRADE D DISSECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE DAY POST INDEX PROCEDURE. THE SUBJECT COMPLETED THE STUDY.

  Patient problems: Vascular Dissection

  MAUDE report 10807315 ↗