HI-TORQUE IRON MAN 1001309Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648013645), received between Sep 18, 2018 and Mar 4, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATE TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. THE IRONMAN GUIDEWIRE WAS ADVANCED HOWEVER MET RESISTANCE WITH THE GUIDING CATHETER AND THE TIP BROKE OFF. THE GUIDING CATHETER AND GUIDE WIRE WERE SIMPLY REMOVED. THE PROCEDURE WAS COMPLETED USING NEW DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513598 ↗
• InjuryOct 1, 2019Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT INFERIOR PULMONARY VEIN WITH NOTED OBSTRUCTION. BALLOON DILATATION WAS PERFORMED. AN IRON MAN GUIDE WIRE (GW) WAS INSERTED INTO A 6FR LONG SHEATH THAT WAS CONNECTED WITH A VALVE Y-CONNECTOR, IN ORDER TO CROSS THE LESION. HOWEVER, THE GW INTERFERED WITH THE DISTAL END OF THE LONG SHEATH, THE COILED PART OF GW THEN BECAME SEPARATED. THE SEPARATED PORTION OF THE GW REMAINED INSIDE THE LONG SHEATH, AND WAS RETRIEVED BY USING A SNARE CATHETER. THE DEVICE WAS REPLACED WITH A NEW IRON MAN GW TO CONTINUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. 10/8/2019: ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE GUIDE WIRE FELT RESISTANCE WITH THE SHEATH DURING REMOVAL AND THEN BECAME SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142445 ↗
• InjurySep 18, 2018Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CORONARY SINUS. A 014 IRONMAN GUIDE WIRE WAS ADVANCED TO THE CORONARY SINUS. THE LEAD OF THE PACEMAKER WAS ADVANCED OVER THE GUIDE WIRE AND THE PACE MAKER WAS PLACED IN THE CORONARY SINUS. DURING REMOVAL OF THE GUIDE WIRE, THE GUIDE WIRE BECAME STUCK WITH THE LEAD OF THE PACEMAKER. EXCESSIVE FORCE WAS APPLIED WHEN THE TIP OF THE GUIDE WIRE BROKE OFF [DETACHED]. THE REMAINDER OF THE GUIDE WIRE WAS SIMPLY REMOVED, BUT THE BROKEN TIP REMAINED EMBEDDED IN THE CORONARY SINUS, ENDING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7885659 ↗