HI-TORQUE INFILTRAC 1030001JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648233692), received between Oct 15, 2020 and Dec 21, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC OCCLUDED, HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. WHEN ADVANCING THE INFILTRAC GUIDEWIRE USING THE ANTEROGRADE TECHNIQUE THE GUIDE WIRE CAUSED A DISSECTION. THE GUIDE WIRE WAS REMOVED, AND A BALLOON WAS USED TO TREAT THE DISSECTION. THERE WAS NO ISSUE DURING ADVANCEMENT, THE PHYSICIAN BELIEVES THERE IS NO PROBLEM WITH INFILTRAC AND THAT THE POROUS CHARACTERISTIC OF THE GUIDE WIRE TIP CONTRIBUTED IN THIS CASE. HE ALSO MENTIONED THE INFILTRAC MAY BE MORE SUCCESSFUL IF IT IS DIRECTED WITH THE AID OF A MICROCATHETER TO THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 13056446 ↗
• InjuryDec 20, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT CORONARY ARTERY. DURING USE OF THE INFILTRAC GUIDE WIRE, IT COULD NOT CROSS THE LESION DUE TO THE EXTREMELY CALCIFIED PLAQUE. THE TIP SEPARATED AND IT IS TRAPPED IN AN EXTREMELY CALCIFIED CHRONIC TOTAL OCCLUSION IN THE LEFT MAIN ARTERY. THERE WAS RESISTANCE WITH THE ANATOMY AND FORCE WAS APPLIED DURING REMOVAL. THE REST OF THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY BUT THE TIP REMAINS IN THE PATIENT IN AN AREA WHERE IT WILL NOT BRING COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13048440 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE HT INFILTRAC GUIDE WIRE WAS ADVANCED THROUGH THE UNSPECIFIED LESION; HOWEVER, A DISSECTION WAS OBSERVED IN THE DISTAL PORTION OF THE MARGINAL VESSEL AND DISTAL DESCENDING ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 12688957 ↗
• MalfunctionOct 15, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED CIRCUMFLEX VESSEL (LCX). A HI-TORQUE INFILTRAC GUIDE WIRE WAS ADVANCED TO THE END OF A NON-ABBOTT MICROCATHETER; HOWEVER, THE GUIDE WIRE WAS ONLY ADVANCED 1-2 CM PAST THE TIP OF THE MICROCATHETER AS THE TIP COULD NOT BE ADEQUATELY SEEN UNDER FLUOROSCOPY TO PLACE IN THE OSTIUM OF THE CIRCUMFLEX VESSEL. THE GUIDE WIRE WAS REMOVED. 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 10685470 ↗