VascuTrak® V186040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741061752), received between Dec 7, 2018 and Nov 30, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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.

• MalfunctionNov 30, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906185 ↗
• MalfunctionJul 16, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V186040 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO CROSS LESION AND HAD A KINKED CATHETER SHAFT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286927 ↗
• MalfunctionJan 15, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V186040 VASCUTRACK PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION (KINK) AND DIFFICULT TO INSERT ISSUES. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT'S AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594171 ↗
• MalfunctionDec 7, 2018Retraction Problem; Device-Device Incompatibility; Material Deformation; Retraction Problem; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA THE SCORING WIRE OF THE PTA BALLOON ALLEGEDLY KINKED DURING THE SECOND INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE REMOVING THE GUIDEWIRE FROM THE BALLOON. REPORTEDLY, THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. 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 8144319 ↗