VascuTrak® V1840150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741061585), received between Dec 27, 2016 and Sep 23, 2024 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, IT WAS FOUND THAT THE PTA BALLOON ALLEGEDLY COULD NOT BE REMOVED FROM THE BODY. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS WITHDRAWN FROM THE BODY AFTER AN ALLEGED EXTRACORPOREAL PUNCTURE OF THE BALLOON WITH A MICRO PENETRATING NEEDLE UNDER THE CONTRAST MEDIUM TO RELIEVE THE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276688 ↗
• MalfunctionJul 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V1840150 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A 67-YEAR-OLD FEMALE WEIGHING 55 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279721 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING OF THE DEVICE, THE EXTERNAL WIRE OF THE PTA BALLOON WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7696783 ↗
• InjuryDec 27, 2016Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT DEFLATE DURING THE FIRST ATTEMPT; THEREFORE, A NEEDLE STICK THROUGH THE SKIN WAS REQUIRED TO DEFLATE THE BALLOON. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6205226 ↗