ULTRASCORE US35130512Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741116780), received between Jun 27, 2019 and Feb 9, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Difficult to Remove

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE WIRE ALLEGEDLY DETACHED FROM BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290363 ↗
• MalfunctionJan 30, 2026Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO REMOVE FORM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219173 ↗
• MalfunctionJan 8, 2026Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON GUIDEWIRE ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000418 ↗
• MalfunctionSep 1, 2024Difficult to Remove; Stretched; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Stretched; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON GOT STUCK IN THE GUIDEWIRE. REPORTEDLY, THE SHEATH NEEDED TO BE REMOVED WITH THE BALLOON STUCK INSIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115636 ↗
• MalfunctionMar 5, 2024Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE RETRIEVED FROM THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT SNAPPED AND REMAINED INSIDE THE SHEATH. REPORTEDLY, THE RESIDUAL CATHETER ALLEGEDLY SLIPPED OUT SLIGHTLY UPON WITHDRAWING THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836741 ↗
• MalfunctionNov 8, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA THE LEFT FEMORAL ARTERY CROSSOVER APPROACH, THE SHAFT OF THE PTA BALLOON ALLEGEDLY SEEMED TO BE BURST DURING THE SECOND INFLATION. IT WAS FURTHER REPORTED THAT UPON INVESTIGATION, A LEAKAGE AT THE SHAFT WHERE THE SHAFT WAS CONNECTED TO THE PRESSURE SYRINGE, WAS NOTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090772 ↗
• 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, 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 11257525 ↗
• InjuryApr 13, 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, APPROXIMATELY 11-MONTH AND 15 DAYS THE FIRST PATIENT EXPERIENCED 80% STENOSIS OF TARGET LESION AND REVASCULARIZATION WAS PERFORMED. IT WAS FURTHER REPORTED THAT, APPROXIMATELY 14 DAYS THE PATIENT EXPERIENCED SECOND 50% STENOSIS OF TARGET LESION AND REVASCULARIZATION WAS PERFORMED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9955504 ↗
• InjuryJun 27, 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 WITH A FOCUSED FORCED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, FOLLOWING USE OF THE STUDY DEVICE, STENT WAS PLACED FOR ELASTIC RECOIL IN MID SFA.

  Patient problems: Injury

  MAUDE report 8742132 ↗