ULTRASCORE US3513068Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741116865), received between Aug 7, 2018 and Feb 20, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED STENOSIS OF A POPLITEAL ARTERY VIA THE LEFT GROIN, THE PTA BALLOON ALLEGEDLY FAILED TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED AND HAD VERY HARD RESISTANCE. IT WAS FURTHER REPORTED THAT THE WIRES ALLEGEDLY DETACHED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738972 ↗
• MalfunctionJan 23, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT LEG VIA RIGHT FEMORALIS COMMUNIS, THE FLUID ALLEGEDLY DROPPED OUT BETWEEN THE CONNECTION HUB AND THE CATHETER WHEN PRESSURE WAS APPLIED TO THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562424 ↗
• InjuryJan 23, 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 PROXIMAL 1/3 AND MID 1/3 OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED WHICH REQUIRED PLACEMENT OF A STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8272515 ↗
• InjuryNov 29, 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 THREE INFLATIONS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A DRUG ELUTING STENT. THE EVENT WAS CONSIDERED TO BE RESOLVED. THE SUBJECT WAS DISCHARGED ONE DAY AFTER THE INDEX PROCEDURE.

  Patient problems: Occlusion; Vascular Dissection

  MAUDE report 8118464 ↗
• InjuryAug 7, 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 INFLATION IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A NON DRUG COATED PTA BALLOON DILATATION CATHETER AND THE EVENT WAS CONSIDERED TO BE RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 7760420 ↗