HI-TORQUE PILOT 1010485-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648073953), received between Feb 20, 2018 and Jun 17, 2024 — classified as 2 injuries, 4 malfunctions.

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

• MalfunctionJun 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BEFORE OPENING, THE PACKAGE OF THE PILOT GUIDE WIRE WAS NOTED TO HAVE A SEPARATED PIECE OF WIRE INSIDE THE PACKAGE. THE DEVICE WAS NOT OPENED OR USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548599 ↗
• MalfunctionSep 30, 2019Difficult to Remove; Material Deformation; Material Twisted/Bent; Difficult to Remove; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT LASER ATHERECTOMY WAS PERFORMED OVER THE HI TORQUE PILOT GUIDE WIRE IN THE CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (PROXIMAL TO DISTAL SEGMENTS WERE CTO) AND THE PROCEDURE WAS COMPLETE. THE LASER ATHERECTOMY DEVICE WAS REMOVED FROM THE GUIDE WIRE AND THE PATIENT. WHEN ATTEMPT WAS MADE TO REMOVE THE PILOT GUIDE WIRE, IT RETRACTED A LITTLE, BUT THEN BECAME STUCK. THE GUIDE WIRE WAS RE-ADVANCED AND WAS THEN SIMULTANEOUS REMOVED AS A UNIT WITH THE NON-ABBOTT CORSAIR MICROCATHETER THAT WAS ALREADY IN PLACE. ONCE THE DEVICES WERE REMOVED OUTSIDE THE ANATOMY, THE PHYSICIAN WAS ABLE TO REMOVE THE GUIDE WIRE FROM THE MICROCATHETER USING A LOT OF FORCE; THERE WAS A LOT OF RESISTANCE. HE THEN NOTED THAT EITHER THE COATING OR THE COILS OF THE GUIDE WIRE WERE FRAYED AND BUNCHED UP. IN THE OPINION OF THE PHYSICIAN, IT IS POSSIBLE THAT THE HEAT FROM THE LASER ATHERECTOMY MAY HAVE CONTRIBUTED TO THE DEVICE ISSUE OF THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS THIS WAS THE END OF THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134755 ↗
• MalfunctionSep 20, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE LEG, TWO HI-TORQUE PILOT 200 GUIDE WIRES WERE USED. THERE WAS NO REPORTED DEVICE ISSUE WITH EITHER GUIDE WIRE AND NO REPORTED ADVERSE PATIENT EFFECT. HOWEVER, AT SOME TIME, IT WAS NOTED THAT THE GUIDE WIRES HAD BEEN USED AFTER EXPIRATION DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895841 ↗
• MalfunctionSep 20, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE LEG, TWO HI-TORQUE PILOT 200 GUIDE WIRES WERE USED. THERE WAS NO REPORTED DEVICE ISSUE WITH EITHER GUIDE WIRE AND NO REPORTED ADVERSE PATIENT EFFECT. HOWEVER, AT SOME TIME, IT WAS NOTED THAT THE GUIDE WIRES HAD BEEN USED AFTER EXPIRATION DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895820 ↗
• InjuryMar 15, 2018Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THIS WAS A VERY COMPLEX CASE. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL ARTERY THAT WAS HEAVILY CALCIFIED, HEAVILY TORTUOUS AND A CHRONIC TOTAL OCCLUSION. THE HI-TORQUE PILOT 200 GUIDE WIRE WAS ADVANCED WHEN THE TIP OF THE PILOT 200 BECAME STUCK IN THE CALCIUM IN THE SUBINTIMAL SPACE AND BROKE OFF. THE TRUE LUMEN WAS CROSSED AND STENTED THE VESSEL BURYING THE SMALL WIRE TIP IN THE TISSUES WITHOUT ANY CONTACT WITH THE LUMEN OF THE VESSEL. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 AND IS DOING WELL POST-PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7341821 ↗
• InjuryFeb 20, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CHRONIC TOTALLY OCCLUDED, HEAVILY CALCIFIED, DISTAL OBTUSE MARGINAL VESSEL, A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AND PILOT GUIDE WIRE WERE USED WITHOUT RESISTANCE. UNDER FLUOROSCOPY, THE GUIDE WIRE TIP DIDN'T LOOK RIGHT, SO THE WIRE WAS REMOVED, BUT THE TIP HAD DETACHED AT THE MARKER AND REMAINED IN THE ANATOMY. A DIFFERENT FIELDER XT GUIDE WIRE AND A 2.25 UNSPECIFIED STENT WERE USED TO COMPRESS THE WIRE FRAGMENT TO THE VESSEL WALL AND TREAT THE LESION. TIMI 2 FLOW WAS RESTORED TO THE VESSEL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7283583 ↗