ULTRASCORE US14150415Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741113727), received between Apr 21, 2022 and Apr 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY STUCK WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764304 ↗
• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 5 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501554 ↗
• MalfunctionJul 30, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 4 ATM. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT IN RETRACTING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19859385 ↗
• MalfunctionNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM DURING LESION EXPANSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117719 ↗
• MalfunctionAug 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154616 ↗
• MalfunctionApr 21, 2022Difficult to Remove; Connection Problem; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Connection Problem; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA A CROSS OVER APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY, THE COVER FOR THE CONNECTION PART OF THE HUB AND THE SHAFT ALLEGEDLY MISALIGNED UPON CONNECTING TO THE INFLATION DEVICE. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE FELT UPON RETRACTING THE BALLOON THROUGH THE SHEATH AND THE TIP OF THE CATHETER WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166882 ↗