HI-TORQUE PILOT 1010481-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648073878), received between Jun 19, 2018 and Jul 14, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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.

• InjuryJul 14, 2023Difficult 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 A MILDLY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 014 HI-TORQUE PILOT 150 GUIDE WIRE (GW) WAS ADVANCED WITH THE INTENT OF OPENING THE OCCLUDED LESION. THE GUIDE WIRE FAILED TO OPEN THE LESION AFTER SEVERAL ATTEMPT, AND THE TIP OF THE GUIDE WIRE BECAME STUCK IN THE OCCLUDED LESION AND COULD NOT BE WITHDRAWN. THE GUIDE WIRE WAS PULLED OUT OF THE ANATOMY AND THE TIP SEPARATED AND REMAINED IN THE OCCLUDED LESION. NO ATTEMPTS WERE MADE TO REMOVE THE TIP, AND NO DEVICE WAS USED TO EMBED THE TIP IN THE LESION. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS RETURNED TO THE WARD. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17325509 ↗
• MalfunctionOct 9, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED MID RIGHT CORONARY ARTERY. AN ALLSTAR GUIDE WIRE WAS REMOVED FROM THE DISPENSER COIL WITHOUT RESISTANCE AND IT WAS NOTED THAT THE GUIDE WIRE COILS WERE STRETCHED. THE COILS AND CORE OF THE GUIDE WIRE DID NOT SEPARATE. A NON-ABBOTT GUIDE WIRE WAS USED SUCCESSFULLY. A .014 HI-TORQUE PILOT 150 GUIDE WIRE WAS ADVANCED IN THE ARTERY; HOWEVER, UNUSUAL RESISTANCE WAS FELT WHILE ADVANCING AN UNSPECIFIED NON-COMPLIANT BALLOON CATHETER OVER THE GUIDE WIRE. THE PILOT 150 GUIDE WIRE WAS REMOVED. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED A SEPARATED PORTION OF POLYMER THAT WAS NOT REPORTEDLY NOTED. NO PORTION OF THE DEVICE REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173365 ↗
• MalfunctionJun 19, 2018Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 100% STENOSED. THE HI-TORQUE PILOT 50 GUIDE WIRE FAILED TO CROSS DUE TO THE PATIENT ANATOMY. THERE WERE NO OTHER DEVICE ISSUES, HOWEVER, DURING REMOVAL, THERE WAS RESISTANCE MET WITH THE ANATOMY. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613602 ↗