VascuTrak® V1850200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741061707), received between Jul 18, 2020 and Aug 31, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (2 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 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.

• InjuryAug 31, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY UNABLE TO DEFLATE. THE PROCEDURE WAS COMPLETED BY USING A NEEDLE STICK TO DEFLATE THE BALLOON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10474934 ↗
• MalfunctionJul 18, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL V1850200 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT WAS 73 YEARS OLD AND WEIGHT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293427 ↗