ULTRASCORE US14150630Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741114106), received between Feb 11, 2022 and Feb 2, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Difficult to Remove

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE VIA THE SUPERFICIAL FEMORAL ARTERY USING THE ULTRASCORE 014 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER COULD NOT BE REINSERTED AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232631 ↗
• MalfunctionJul 15, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRASCORE 014 IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON CATHETER ALLEGEDLY WAS STUCK WITH THE GUIDEWIRE AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON CATHETER WAS ALLEGEDLY STUCK WITH THE INTRODUCER SHEATH TIP AND COULD NOT BE INSERTED INTO THE INTRODUCER SHEATH AND WAS REMOVED TOGETHER WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22504098 ↗
• MalfunctionJun 9, 2025Break; Break

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PASS THE LESION, THE BALLOON SHAFT BROKE AND CONTINUED USE WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168812 ↗
• MalfunctionApr 30, 2025Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING AN ULTRASCORE 014 BALLOON, IT GOT STUCK UNDER NOMINAL PRESSURE. FURTHER THERE WAS DIFFICULTY IN ADVANCING THE DEVICE THROUGH THE GUIDEWIRE. ADDITIONALLY, THERE WAS DIFFICULTY RETRACTING THE DEVICE THRU THE INTRODUCER SHEATH OR REMOVING FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932471 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 5 ATM DURING LESION EXPANSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822929 ↗
• MalfunctionJan 20, 2025Material 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 21189563 ↗
• MalfunctionJul 22, 2024Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AFTER EXPANSION AT 7 ATM, THE PTA BALLOON ALLEGEDLY DID NOT COME OUT. IT WAS FURTHER REPORTED THAT THE ENTIRE BALLOON ALONG WITH THE WIRE HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790248 ↗
• MalfunctionNov 6, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, THE DEVICE ALLEGEDLY FAILED TO BE RETRACTED FROM THE SHEATH AFTER INFLATING. IT WAS FURTHER REPORTED THAT 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 18071276 ↗
• MalfunctionMar 17, 2022Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING 5FR SHEATH, THE PTA BALLOON WAS ALLEGEDLY STUCK UPON REMOVAL FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE BALLOON AND THE SHEATH WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13798469 ↗
• MalfunctionFeb 11, 2022Inflation Problem; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent; Material Split, Cut or Torn; Inflation Problem; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, A PORTION OF THE PTA BALLOON ALLEGEDLY TWISTED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THERE WAS STRONG RESISTANCE FELT UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13512778 ↗