ULTRASCORE US14150530Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741114007), received between Aug 2, 2022 and Jan 6, 2026 — classified as 15 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 BALLOON CATHETER VIA FEMORAL APPROACH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971228 ↗
• MalfunctionFeb 4, 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 21301511 ↗
• MalfunctionJan 3, 2025Difficult to Insert; Device-Device Incompatibility; Device Dislodged or Dislocated; Difficult to Insert; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY DID NOT ADVANCE INTO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064536 ↗
• MalfunctionOct 14, 2024Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent; Deflation Problem; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON TIP ALLEGEDLY BECAME STUCK WITH THE GUIDEWIRE WHEN IT REACHED THE COMMON FEMORAL ARTERY, BUT GRADUALLY SUCCEEDED IN DELIVERING IT TO THE DISTAL PART. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF PAIN DUE TO THE TIP OF THE GUIDEWIRE HAD ALREADY PASSED OUTSIDE THE BLOOD VESSEL. FURTHERMORE, THE HEALTHCARE PROFESSIONAL DECIDED TO PERFORM BALLOON DILATATION, BUT IT ALLEGEDLY COULD NOT BE DEFLATED. REPORTEDLY, IT BECAME IMPOSSIBLE TO REMOVE THE BALLOON, AND IT WAS DEFLATED BY FORCIBLY PUNCTURING THE BALLOON FROM THE SURFACE OF THE BODY WITH A NEEDLE AND THEN REMOVED IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438781 ↗
• MalfunctionJul 29, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19857955 ↗
• MalfunctionJul 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM OF THE FIRST EXPANSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824481 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958282 ↗
• MalfunctionOct 26, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009281 ↗
• MalfunctionSep 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835279 ↗
• MalfunctionMay 25, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE AFTER INFLATION AT FIRST INFLATION ATTEMPT AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED GRADUALLY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000697 ↗
• MalfunctionMay 12, 2023Deflation Problem; Air/Gas in Device; Deflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY, THE CONTRAST MEDIUM WAS ALLEGEDLY UNABLE TO BE ASPIRATED WHEN THE DEVICE WAS ATTEMPTED TO DEFLATE AFTER INFLATING THE BALLOON. REPORTEDLY, THE NEEDLE WAS PUNCTURED FROM THE PATIENT¿S BODY SURFACE TOWARD TO THE BALLOON AND THE DEVICE 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 16917389 ↗
• MalfunctionNov 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE HUB AND THE GRAY RUBBER CONNECTION PART OF THE HUB WERE ALLEGEDLY FOUND DISLODGED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS RE CONNECTED BY FORCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875752 ↗
• MalfunctionOct 11, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE SINCE THE BODY WIRE GOT STUCK WITH THE STENT AFTER INFLATION. IT WAS FURTHER REPORTED THAT STRONG FORCE APPLIED TO REMOVE THE PTA BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576440 ↗
• MalfunctionAug 29, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY STUCK WITH THE STENT DEPLOYED IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309047 ↗
• MalfunctionAug 2, 2022Difficult 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 AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY GOT STUCK AND FAILED TO BE REMOVED THE DEVICE FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PTA BALLOON AND THE GUIDEWIRE WAS REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15144308 ↗