HI-TORQUE IRON MAN 1001309JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648015748), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2019Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY THAT WAS 70% STENOSED. AN UNSPECIFIED BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE MET RESISTANCE WITH AN UNSPECIFIED BALLOON CATHETER DURING ADVANCEMENT. THEREFORE, A 014 IRON MAN GUIDE WIRE WAS USED AS A BUDDY WIRE; HOWEVER, THE IRON MAN GUIDE WIRE BECAME ENTANGLED WITH THE BMW GUIDE WIRE DURING REMOVAL. THE IRON MAN GUIDE WIRE COIL THEN UNRAVELED AND THE TIP SEPARATED OUTSIDE THE ANATOMY WHEN IT WAS REMOVED INDEPENDENTLY. THE BMW GUIDE WIRE WAS REMOVED AFTER THE PROCEDURE WAS COMPLETED AND IT WAS NOT DAMAGED. 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 8283038 ↗