ULTRASCORE US141502H15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741113420), received between Feb 27, 2023 and Jun 18, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER FOR SEVERELY CALCIFIED TARGET LESION BELOW THE KNEE VIA AN IPSILATERAL ANTEGRADE APPROACH. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED AT BELOW THE NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22281711 ↗
• InjuryJan 7, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE VASCULAR RUPTURE HAD ALLEGEDLY OCCURRED AT 6 ATM AND ADDITIONAL LONG INFLATION SUCCESSFULLY STOPPED THE BLEEDING. FURTHERMORE, THERE WAS ALLEGEDLY A RESISTANCE IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH BUT IT WAS POSSIBLE TO RETRACT IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21096251 ↗
• MalfunctionFeb 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE KNEE VIA AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441860 ↗