HI-TORQUE PILOT 1010484-HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648073946), received between Nov 3, 2023 and Nov 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 16, 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.

• MalfunctionNov 25, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING LOADING OF THE DISTAL END OF THE HI-TORQUE (HT) PILOT 150 GUIDE WIRE TO THE GUIDE WIRE INTRODUCER THAT IS NOT ATTACHED TO THE ANATOMY, THE GUIDE WIRE COULD NOT BE ADVANCED. THE GUIDE WIRE INTRODUCER WAS THEN LOADED TO THE PROXIMAL END OF THE HT PILOT 150 GUIDE WIRE AND ADVANCED WITHOUT RESISTANCE TO THE DISTAL END WHEN THE COATING SHEARED OFF AND SEPARATED FROM THE GUIDE WIRE. A HT PILOT 50 GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR DEVICE USE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207614 ↗
• MalfunctionNov 3, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED DURING PREPARATION OF TWO 014 HI-TORQUE PILOT 150 GUIDE WIRES (GW), THE DEVICES WERE ATTEMPTED TO BE ADVANCED INTO THE GUIDE WIRE INTRODUCER FROM THE DISTAL FLOPPY END. NEITHER GW COULD BE ADVANCED, SO THEY WERE BOTH ATTEMPTED TO BE BACKLOADED THROUGH THE INTRODUCER FROM THE PROXIMAL END AND THE DISTAL END OF THE POLYMER COATING OF THE GUIDE WIRES SHEARED OFF. THE GUIDE WIRES WERE NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS PREPPED AND USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067715 ↗
• MalfunctionNov 3, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED DURING PREPARATION OF TWO 014 HI-TORQUE PILOT 150 GUIDE WIRES (GW), THE DEVICES WERE ATTEMPTED TO BE ADVANCED INTO THE GUIDE WIRE INTRODUCER FROM THE DISTAL FLOPPY END. NEITHER GW COULD BE ADVANCED, SO THEY WERE BOTH ATTEMPTED TO BE BACKLOADED THROUGH THE INTRODUCER FROM THE PROXIMAL END AND THE DISTAL END OF THE POLYMER COATING OF THE GUIDE WIRES SHEARED OFF. THE GUIDE WIRES WERE NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS PREPPED AND USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067702 ↗