ULTRASCORE US1415074Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741114120), received between Sep 14, 2022 and Sep 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• MalfunctionSep 9, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON BECAME STUCK WITH THE GUIDEWIRE DURING REMOVAL. AND THERE WAS STRONG RESISTANCE FELT AND WAS UNABLE TO REMOVE IT. AFTER THREE OR FOUR ATTEMPTS, CUSTOMER WAS FORCED TO REMOVE THE ENTIRE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001689 ↗
• MalfunctionJun 18, 2025Break; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER FOR ILIAC OCCLUSION DILATION. DURING THE PROCEDURE, THE WIRE WAS ALLEGEDLY DIFFICULT TO REMOVE AFTER BALLOON DILATION. IT WAS FURTHER REPORTED THAT THE BALLOON PART WAS DEFORMED, THE SHAFT OF THE BALLOON PART WAS BROKEN, AND IT WAS NO LONGER POSSIBLE TO INSERT THE WIRE AGAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22265494 ↗
• MalfunctionJan 18, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532126 ↗
• MalfunctionSep 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE STRAIN RELIEF AT THE Y-BODY OF THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE DISLOCATED UPON REMOVING THE BALLOON FROM ITS COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17771639 ↗
• MalfunctionJan 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE INFLATION PORT OF THE HUB ALLEGEDLY DETACHED BEFORE THE SHEATH INSERTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16081950 ↗
• MalfunctionSep 14, 2022Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 4ATM. 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 15415759 ↗