ULTRASCORE US14150610Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741114052), received between Mar 31, 2022 and Apr 28, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916478 ↗
• MalfunctionMar 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN ATTEMPTING TO REMOVE THE BALLOON FROM THE HOOP BEFORE USING IT, THE STRAIN RELIEF HAD COME OFF AND SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729655 ↗
• MalfunctionJan 8, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE INGUINAL ACCESS, WHEN ATTEMPTED TO EXPAND WITH THIS PRODUCT, THE PTA BALLOON WAS ALLEGEDLY STUCK. IT WAS FURTHER REPORTED THAT THE CATHETER AND SHEATH WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106454 ↗
• MalfunctionNov 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769433 ↗
• MalfunctionJul 1, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652487 ↗
• MalfunctionJun 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592386 ↗
• MalfunctionApr 4, 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 19039211 ↗
• MalfunctionFeb 15, 2023Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated; Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE GUIDEWIRE ALLEGEDLY GOT STUCK AFTER INFLATING. IT WAS FURTHER REPORTED THAT THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377981 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL ARTERY VIA AN IPSILATERAL APPROACH, THE TIP OF THE GUIDEWIRE LUMEN ALLEGEDLY CRUSHED AND GOT STUCK WITH THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE AND THE SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453501 ↗
• MalfunctionAug 1, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED WITH RESISTANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137396 ↗
• MalfunctionMar 31, 2022Break; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY AND THE ILIAC ARTERY VIA CONTRALATERAL APPROACH, THE GUIDEWIRE LUMEN AND GUIDEWIRE ALLEGEDLY GOT STUCK. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO REMOVE. REPORTEDLY, THE GUIDEWIRE LUMEN WAS FOUND TO BE DAMAGED. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966079 ↗