ULTRASCORE US14150430Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741113758), received between Aug 2, 2023 and Jul 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 16, 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.

• MalfunctionJul 23, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025 DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ULTRASCORE 014 BALLOON. DURING THE PROCEDURE, A RUPTURE OCCURRED DURING TREATMENT OF A SEVERELY CALCIFIED LESION, MAKING IT UNUSABLE DURING THE FIRST INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574229 ↗
• MalfunctionJun 20, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION USING THE ULTRASCORE. DURING THE PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294822 ↗
• 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 SUPERFICIAL FEMORAL ARTERY OBSTRUCTION VIA THE CONTRALATERAL APPROACH. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22281674 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991860 ↗
• MalfunctionJan 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED BELOW THE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186191 ↗
• MalfunctionJan 9, 2025Break; Inflation Problem; Material Rupture; Break; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY SLOWLY EXPANDED AND PARTIAL POOR EXPANSION WAS OBSERVED. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON WAS EXPANDED TO NOMINAL PRESSURE, IT RUPTURED. REPORTEDLY, WHEN IT WAS PULLED OUT OF THE BODY AND CHECKED, THE BODY WIRE WAS ALSO BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110093 ↗
• MalfunctionOct 18, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479848 ↗
• MalfunctionJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE HUB WAS ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT IT ALLEGEDLY CAME OFF EVEN THOUGH LITTLE FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564602 ↗
• MalfunctionMar 4, 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 HUB OF THE PTA BALLOON ALLEGEDLY CAME OFF THE CATHETER AND THE CATHETER SHAFT WAS ALLEGEDLY SEPERATED AND SLID. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824222 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738581 ↗
• MalfunctionAug 2, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY GOT STUCK WITH THE GUIDEWIRE AND WAS UNABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440970 ↗