ULTRASCORE US1415054Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741113925), received between Sep 1, 2023 and Sep 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionSep 8, 2026Difficult to Remove

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty procedure using an UltraScore 014 balloon catheter. During the procedure, it was reported that the balloon catheter could not be removed. The procedure was completed as intended. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667738 ↗
• MalfunctionSep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226451 ↗
• MalfunctionJul 28, 2024Material Rupture; Failure to Advance; Device-Device Incompatibility; Difficult to Advance; Material Rupture; Failure to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY HAD CONSIDERABLE RESISTANCE TO GUIDEWIRE TRACKING, SO THE LESION WAS REACHED BY PUSHING HARD. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DETERMINED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19848645 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE INITIAL INFLATION, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369098 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE GRAY HUB PART WAS ALLEGEDLY REMOVED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461747 ↗
• MalfunctionDec 18, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE HUB OF THE GUIDE WIRE INFLATION WAS ALLEGEDLY DISCONNECTED WHEN TAKEN OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343328 ↗
• MalfunctionOct 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937862 ↗
• MalfunctionSep 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 17669275 ↗