VascuTrak® V1850150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741061691), received between Sep 21, 2018 and Feb 20, 2026 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Difficult to Remove; Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VASCUTRAK BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398223 ↗
• MalfunctionDec 19, 2022Break; Device Damaged Prior to Use; Device Misassembled During Manufacturing /Shipping; Break; Device Damaged Prior to Use; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, HALF BROKEN GUIDEWIRE WAS ALLEGEDLY OBSERVED ON THE BALLOON TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002907 ↗
• MalfunctionMar 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE FEMORAL ARTERY, THE BALLOON ALLEGEDLY FAILED TO INFLATE, UPON RADIOGRAPHIC INSPECTION FLUID LEAK WAS IDENTIFIED. THE BALLOON WAS WITHDRAWN AND WAS NOTED TO HAVE A RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479275 ↗
• InjuryDec 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A SLIGHTLY CALCIFIED LESION IN THE POPLITEAL ARTERY, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED A NEEDLE STICK TO PERCUTANEOUSLY DEFLATE THE BALLOON. A STENT WAS PLACED AT THE PUNCTURE SITE. PATENCY WAS REPORTEDLY RESTORED POST PROCEDURE. THERE WERE NO FURTHER REPORTED COMPLICATIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9477166 ↗
• InjurySep 21, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. A NEEDLE WAS INSERTED THROUGH THE SKIN TO DEFLATE THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 7898606 ↗