HI-TORQUE IRON MAN 1001311Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648013652), received between Sep 12, 2016 and Jun 24, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Entrapment of Device; Material Separation; Material Too Soft/Flexible; Entrapment of Device; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE IRONMAN GUIDE WIRE WAS ADVANCED TO THE LESION AND TWO XIENCE STENTS WERE DEPLOYED WITHOUT ISSUE. THE GUIDE WIRE WAS BEING REMOVED; HOWEVER, IT WAS NOTED THAT THE TIP WAS KNOTTED AND STUCK ON THE END OF THE DEPLOYED 3.5X18 MM XIENCE SKYPOINT STENT. A MICROCATHETER WAS USED IN AN ATTEMPT TO REMOVE THE GUIDE WIRE BUT THE TIP SEPARATED AND WAS LEFT ON THE EDGE OF THE DEPLOYED STENT. THE TIP WAS BALLOONED INTO THE XIENCE STENT AND LEFT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22321071 ↗
• InjuryMay 28, 2025Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE INFERIOR MESENTERIC ARTERY. A NON-ABBOTT STENT WAS PLACED AND THE IRONMAN GUIDE WIRE TIP BECAME CAUGHT IN THE IMPLANTED STENT DURING REPOSITIONING. DURING RETRACTION RESISTANCE WAS MET AND FORCE WAS APPLIED, THE TIP THEN BROKE OFF. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION HOWEVER WAS UNSUCCESSFUL. A BRACHIAL CUTDOWN WAS PERFORMED AND ANOTHER SNARE WAS ADVANCED HOWEVER WAS STILL UNABLE TO REMOVE THE SEPARATED PORTION. ANOTHER STENT WAS IMPLANTED TO EMBED THE SEPARATED WIRE TIP. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22094828 ↗
• InjurySep 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 014 IRON MAN GUIDE WIRE WAS ADVANCED TO THE HEAVILY CALCIFIED SFA AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PROCEDURE WAS COMPLETED. AFTER REMOVAL OF THE IRON MAN GUIDE WIRE, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED. THE SEPARATED SEGMENT WAS SUCCESSFULLY REMOVED VIA A SNARE DEVICE. 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 10543893 ↗
• InjuryFeb 25, 2019Entrapment of Device; Failure to Advance; Device Damaged by Another Device; Entrapment of Device; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH RESTENOSIS. THE PATIENT HAD A DOUBLE LAYER OF UNSPECIFIED STENTS, AND WHEN THE IRONMAN GUIDE WIRE (GW) WAS ADVANCING, THE GW BECAME STUCK IN BETWEEN THE STENTS. THE PHYSICIAN ATTEMPTED TO REMOVE THE GW; HOWEVER, THE STENTS BECAME ACCORDION-LIKE; AND THEREFORE, THE GW COULD NOT BE REMOVED. THE PATIENT WAS SENT TO BYPASS SURGERY. THE GW WAS CUT, AND THE DISTAL PORTION WAS LEFT TO REMAIN STUCK IN BETWEEN THE STENTS BECAUSE IT COULD NOT BE RETRIEVED IN ANY WAY. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU) AND HAS TWO INFECTIONS AT UNKNOWN LOCATIONS AND DELIRIUM. IT WAS NOTED THAT THE PATIENT DEVELOPED A LIVER ISSUE NOT RELATED TO USE OF THE DEVICE. PER THE PHYSICIAN, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE LIVER ISSUE, DELIRIUM OR INFECTIONS. NO ADDITIONAL TREATMENT HAS BEEN GIVEN TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Vessel Or Plaque, Device Embedded In

  MAUDE report 8367414 ↗
• MalfunctionJun 11, 2018Peeled/Delaminated

  IT WAS REPORTED AFTER THE IRON MAN GUIDE WIRE WAS UNPACKAGED, IT WAS NOTED THAT THE COATING WAS COMING OFF THE GUIDE WIRE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7588519 ↗
• InjurySep 12, 2016Detachment Of Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE NON-TORTUOUS PERONEAL ARTERY, A 014 IRON MAN GUIDE WIRE WAS ADVANCED PAST THE TARGET LESION WITHOUT RESISTANCE. A NON-ABBOTT ATHERECTOMY DEVICE WAS ADVANCED OVER THE IRON MAN WITHOUT RESISTANCE AND ATHERECTOMY WAS PERFORMED WITHOUT ISSUE. HOWEVER, WHEN THE ATHERECTOMY DEVICE REACHED THE TIP OF THE IRON MAN, IT CAUSED THE TIP TO BUNCH THEN SEPARATE IN A SMALL PERONEAL SIDE-BRANCH VESSEL. THE ATHERECTOMY DEVICE WAS THEN RETRACTED OVER THE IRON MAN WITHOUT RESISTANCE, FOLLOWED BY WITHDRAWAL OF THE IRON MAN GUIDE WIRE WITHOUT DIFFICULTY. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED IRON MAN TIP, BUT THE TIP WAS TOO FAR DISTAL TO BE REACHED. AS THE PHYSICIAN FELT THAT LEAVING THE TIP WOULD NOT CAUSE ADVERSE PATIENT SEQUELAE, THE TIP WAS LEFT IN SMALL SIDE-BRANCH VESSEL. THE ATHERECTOMY PROCEDURE WAS CONSIDERED COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5943846 ↗