VascuTrak® V1840200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741061592), received between Jul 24, 2019 and Jul 24, 2019 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionJul 24, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V1840200 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE TWO MALFUNCTIONS INVOLVED PATIENTS WITH NO KNOWN IMPACT TO THE PATIENT. ONE PATIENT WAS AN 83 YEAR-OLD MALE AND THE OTHER WAS A 53 YEAR-OLD FEMALE, WEIGHTS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824314 ↗
• MalfunctionJul 24, 2019Deflation Problem; Device-Device Incompatibility; Deflation Problem; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V1840200 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DEFLATION ISSUE AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE INVOLVED PATIENT WAS REPORTED TO BE A 69 YEAR OLD FEMALE WITHOUT WEIGHT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823306 ↗