Skip to content

MINI TREK™ 1012402-20ARecalls & reported problems

Abbott Vascular Inc. · MINI TREK™ II Coronary Dilatation Catheter 1.50 mm x 20 mm / Over-The-Wire · Class 2

All models of MINI TREK (25)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648180842), received between Jul 6, 2020 and Sep 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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

Device problems

  • Material Rupture2
  • Difficult to Advance1
  • Inflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2021Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. A 1.5X20MM MINI TREK II BALLOON DILATATION CATHETER (BDC) PARTIALLY INFLATED AND WAS LOSING PRESSURE. THE LEAK WAS NOTED IN THE BALLOON DURING INFLATION. AN UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE 1.5X20MM MINI TREK II BALLOON DILATATION CATHETER (BDC) FACED RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY, AND THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12481654 ↗
  • MalfunctionJul 6, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY TORTUOUS, 99% STENOSED DISTAL RIGHT CORONARY ARTERY. A 1.5X20MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A 1.5X15MM NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10233154 ↗

Other Catheters, transluminal coronary angioplasty, percutaneous devices

All Catheters, transluminal coronary angioplasty, percutaneous devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page