ULTRASCORE US1415044Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741113673), received between Jan 15, 2020 and Sep 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE IN A CASE OF IPSILATERAL ANTEGRADE BK USING AN ULTRASCORE 014. DURING PROCEDURE, ATTEMPTS WERE MADE TO EXPAND THE POP STENOSIS AND THEN REMOVE IT, BUT IT DID NOT COME OUT WHEN THE BALLOON'S TIP MARKER APPROACHED THE ENTRANCE OF THE SHEATH, SO IT WAS PUSHED BACK INTO THE BODY AGAIN, THERE WAS RESISTANCE AND IT WAS DIFFICULT TO PASS. INFLATION AND DEFLATION WERE PERFORMED, AND ATTEMPTS WERE MADE TO REMOVE IT AGAIN, BUT IT DID NOT COME OUT, SO THE SHEATH WAS REMOVED AND TAKEN OUT OF THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936372 ↗
• MalfunctionMar 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED BELOW 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 21603785 ↗
• MalfunctionJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120760 ↗
• MalfunctionJan 6, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BILATERAL ILIAC ARTERY, THE HUB OF THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077077 ↗
• MalfunctionJul 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED LESION, THE PTA BALLOON DILATATION CATHETER WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686681 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE POPLITEAL ARTERY VIA THE COMMON FEMORAL ARTERY IPSILATERAL APPROACH, THE BODY WIRE WAS ALLEGEDLY FOUND TO BE DEFORMED WHILE INSERTING THE BALLOON TIP ALONG THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457301 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 7 ATM ON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179844 ↗
• MalfunctionJan 15, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US1415044. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE, AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS FEMALE; HOWEVER, THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591384 ↗