ULTRASCORE US14150510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741113956), received between Jun 20, 2022 and Feb 10, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE SHAFT WAS ALLEGEDLY BROKE AND KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341471 ↗
• MalfunctionFeb 3, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300574 ↗
• MalfunctionNov 10, 2023Failure to Advance; Device-Device Incompatibility; Material Split, Cut or Torn; Failure to Advance; Device-Device Incompatibility; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108858 ↗
• MalfunctionMay 24, 2023Entrapment of Device; Failure to Advance; Device-Device Incompatibility; Entrapment of Device; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CROSS OVER APPROACH, THE GUIDEWIRE ALLEGEDLY GOT STUCK WITHIN THE CATHETER DURING ADVANCEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991322 ↗
• MalfunctionApr 15, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748411 ↗
• MalfunctionOct 25, 2022Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE BALLOON CATHETER WAS UNABLE TO BE REMOVED FROM THE PACKAGING HOOP. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665609 ↗
• MalfunctionJun 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION, THE PTA BALLOON 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 14741584 ↗