ULTRASCORE US1415064Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741114021), received between Mar 29, 2022 and Jul 18, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN THE IPSILATERAL ANTEGRADE AP APPROACH USING THE ULTRASCORE, AND THE BALLOON ALLEGEDLY RUPTURED BELOW THE NP. FURTHER, THE DEVICE ALLEGEDLY HAD DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541498 ↗
• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER TO TREAT SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH. DURING THE PROCEDURE, THE PRESSURE ESCAPED AT 6 ATM, LEADING TO A DIAGNOSIS OF BALLOON RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282190 ↗
• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. AFTER THAT, EXPANDED IT WITH THE SHIDEN HP AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502649 ↗
• MalfunctionSep 8, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166246 ↗
• MalfunctionMay 2, 2024Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE AFTER INFLATION, THE TIP ALLEGEDLY GOT BROKEN. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY COULD NOT BE REMOVED FROM THE SHEATH. REPORTEDLY, THE CATHETER AND THE SHEATH WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228264 ↗
• MalfunctionApr 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE REMOVED AND HAD TO BE REMOVED ALTOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056562 ↗
• MalfunctionDec 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE COMMON ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049173 ↗
• MalfunctionSep 1, 2022Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY, THE GUIDEWIRE WAS ALLEGEDLY STUCK AND WAS DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THE BALLOON AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. REPORTEDLY, THE BLACK SUBSTANCE NEAR THE DISTAL MARKER WAS ALLEGEDLY NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334421 ↗
• MalfunctionApr 6, 2022Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY VIA RADIAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY STUCK UPON REMOVAL FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE BALLOON AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14019202 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936633 ↗