ULTRASCORE US35130610Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741116872), received between Jul 3, 2018 and Feb 27, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 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.

• MalfunctionFeb 27, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING A FEMORAL CALCIFIC OCCLUSION ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAK FROM THE CONNECTION BETWEEN THE Y AND THE CATHETER SHAFT. IT WAS FURTHER REPORTED THAT THE HUB OF THE CATHETER WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787637 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT SAME DAY POST INDEX PROCEDURE, THERE WAS A SPIRAL DISSECTION AND THE OUTCOME OF ADVERSE EVENT WAS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DRUG COATED BALLOON (DCB) AND BARE METAL STENT WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 12621206 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT FOLLOWING AN ANGIOPLASTY PROCEDURE IN THE DISTAL 1/3 OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED. A BARE METAL STENT WAS PLACED TO TREAT THE LESION.

  Patient problems: Vascular Dissection

  MAUDE report 9220974 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, SERIAL DISSECTIONS WERE IDENTIFIED WHICH RESULTED IN STENT PLACEMENT. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8072347 ↗
• MalfunctionOct 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, ONE OF THE SCORING WIRES OF THE PTA BALLOON WAS FOUND TO BE DETACHED. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7950112 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED AFTER INFLATION IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT AND THE EVENT WAS CONSIDERED TO BE RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 7712919 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER IN THE SUPERFICIAL FEMORAL ARTERY, VESSEL DISSECTION WAS IDENTIFIED. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT; COMPLETION IMAGING DEMONSTRATED RESOLUTION.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 7684298 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED AFTER TWO INFLATIONS IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT; COMPLETION ANGIOGRAM DEMONSTRATED WIDE PATENCY OF THE INTERVENTION.

  Patient problems: Vascular Dissection

  MAUDE report 7661222 ↗