VascuTrak® V1425300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741061288), received between Dec 27, 2017 and Jan 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LOWER LEFT EXTREMITY, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUES. A NEEDLE STICK WAS USED TO PERCUTANEOUSLY DEFLATE THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS TO THE PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9593812 ↗
• MalfunctionDec 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE HUB OF THE PTA BALLOON CATHETER DETACHED DURING REMOVAL FROM THE PATIENT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149854 ↗