ULTRASCORE US35130510Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741116773), received between Jan 10, 2019 and May 14, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Break; Difficult to Remove

  ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS DILATED IN A CALCIFIED SUPERFICIAL FEMORAL ARTERY AND THE WIRE ALLEGEDLY BROKEN. THE BALLOON COULD ONLY BE REMOVED TOGETHER WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171046 ↗
• MalfunctionMay 27, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035. DURING THE PROCEDURE THE SHEATH ALLEGEDLY DIFFICULT TO INSERT. REPORTEDLY THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND WHEN TRYING TO PULL BACK IT GOT TEAR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086286 ↗
• MalfunctionOct 3, 2023Break; Burst Container or Vessel; Leak/Splash; Break; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE LUMEN OF THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858727 ↗
• MalfunctionSep 29, 2022Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY GOT STUCK INSIDE 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 15507528 ↗
• MalfunctionOct 6, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580771 ↗
• MalfunctionSep 30, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551909 ↗
• MalfunctionJul 18, 2020Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL US35130510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM, MATERIAL RUPTURE AND DETACHMENT OF DEVICE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A (B)(6) FEMALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293436 ↗
• InjuryJan 10, 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 FOLLOWING AN ANGIOPLASTY PROCEDURE IN THE DISTAL 1/3 OF THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, NON-FLOW LIMITING DISSECTION WAS IDENTIFIED WHICH REQUIRED USE OF ADDITIONAL PTA BALLOON, DRUG COATED PTA BALLOON, AND PLACEMENT OF STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY TRIAL, APPROXIMATELY 12-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 8237549 ↗