ULTRASCORE US35130520Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741116803), received between Dec 27, 2018 and Sep 4, 2024 — classified as 7 injuries, 1 malfunction.

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 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 4, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY LEAKED FROM THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135091 ↗
• InjuryJan 14, 2020Adverse 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 AFTER USE OF A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED. THIRTY DAYS AFTER AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER WAS PERFORMED, STENOSIS WAS IDENTIFIED VIA DUPLEX ULTRASOUND. APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, RE-INTERVENTION WAS PERFORMED USING A BARE METAL STENT.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 9586859 ↗
• InjuryJun 11, 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 APPROXIMATELY 7-MONTH POST ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, STENOSIS WAS IDENTIFIED IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS FURTHER REPORTED REVASCULARIZATION WAS PERFORMED USING PTA BALLOON.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8689001 ↗
• InjuryMar 6, 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 MID 1/3 OF THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULT OF A CLINICAL TRIAL THAT APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, TARGET LESION REVASCULARIZATION WAS OCCURRED. IT WAS FURTHER REPORTED THAT A STENT WAS PLACED WITH FOLLOWING BALLOON DILATATION CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. NEW INFORMATION: IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, DUPLEX ULTRASOUND WAS PERFORMED AND IDENTIFIED STENOSIS.

  Patient problems: Vascular Dissection

  MAUDE report 8397371 ↗
• InjuryFeb 20, 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 DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, NON FLOW-LIMITING VESSEL DISSECTION WAS IDENTIFIED AFTER TWO INFLATIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND THE PATIENT WAS HOSPITALIZED. REPORTEDLY, PTA, DRUG COATED BALLOON PTA, BARE METAL STENTING AND MECHANICAL THROMBECTOMY WERE PERFORMED AND THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT WAS DISCHARGED ONE DAY POST ADMISSION.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8356501 ↗
• InjuryFeb 15, 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 DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, FOLLOWING USE OF THE STUDY DEVICE PTA ANGIOGRAPHY DEMONSTRATED MICROPERFORATIONS AND AV FISTULA. THE TARGET LESION WAS TREATED WITH A PTA BALLOON AND ADEQUATE FLOW WAS IDENTIFIED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fistula; Perforation

  MAUDE report 8346329 ↗
• InjuryJan 24, 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 MID 1/3 AND DISTAL 1/3 OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED WHICH REQUIRED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, DRUG COATED PTA BALLOON, AND PLACEMENT OF TWO STENTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8276555 ↗
• InjuryDec 27, 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 (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED AFTER ONE INFLATION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT. THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT WAS DISCHARGED THE SAME DAY AS THE INDEX PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8200874 ↗