HI-TORQUE PILOTRecalls & reported problems across all models

We found 11 models of HI-TORQUE PILOT by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Aug 18, 2026 — classified as 1 death, 27 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (38 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HI-TORQUE PILOT problems

HI-TORQUE PILOT models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HI-TORQUE PILOT 1010480-H

  WIRE, GUIDE, CATHETER
  27 reports
• HI-TORQUE PILOT 1010480-HJ

  WIRE, GUIDE, CATHETER
  19 reports
• HI-TORQUE PILOT 1010482-H

  WIRE, GUIDE, CATHETER
  7 reports
• HI-TORQUE PILOT 1010485-H

  WIRE, GUIDE, CATHETER
  6 reports
• HI-TORQUE PILOT 1010482-HJ

  WIRE, GUIDE, CATHETER
  4 reports
• HI-TORQUE PILOT 1010481-H

  WIRE, GUIDE, CATHETER
  3 reports
• HI-TORQUE PILOT 1010484-HJ

  WIRE, GUIDE, CATHETER
  3 reports
• HI-TORQUE PILOT 1010483-H

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE PILOT 1010484-H

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE PILOT 1010481-HJ

  WIRE, GUIDE, CATHETER
  1 report
• HI-TORQUE PILOT 1010483-HJ

  WIRE, GUIDE, CATHETER
  1 death1 report

Recent HI-TORQUE PILOT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303401 ↗
• MalfunctionAug 18, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303394 ↗
• InjuryNov 20, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TOTALLY OCCLUDED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. MULTIPLE NON-ABBOTT GUIDE WIRES WERE ATTEMPTED HOWEVER FAILED TO CROSS THE LESION. DURING ADVANCEMENT OF THE PILOT GUIDE WIRE RESISTANCE WAS MET WITH THE ANATOMY. DURING ROTATION AND WITHDRAWAL RESISTANCE WAS MET WITH THE ANATOMY AND THE DISTAL PORTION OF THE GUIDE WIRE SEPARATED AND REMAINED IN THE CORONARY ARTERY. ATTEMPTS WERE MADE TO REMOVE THE SEPARATED PORTION WITH A SNARE DEVICE HOWEVER WERE UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23606080 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE HI TORQUE PILOT 50 GUIDE WIRE WAS ADVANCED TO THE LESION. THE LESION WAS THEN PRE-DILATED WITH A 2.5X12 MM SEMI-COMPLIANT BALLOON. THE BALLOON WAS ATTEMPTED TO BE REMOVED BUT IT WAS STUCK WITH THE GUIDE WIRE SO THE DEVICES WERE REMOVED TOGETHER. ANOTHER PILOT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469528 ↗
• MalfunctionNov 4, 2025Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE HI TORQUE PILOT GUIDE WIRE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. UPON REMOVAL FROM THE ANATOMY IT WAS NOTED THAT THE POLYMER COATING WAS PEELING. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467431 ↗
• MalfunctionMay 7, 2025Peeled/Delaminated; Stretched; Peeled/Delaminated; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 80% STENOSED. THE .014 HI-TORQUE PILOT 50 GUIDE WIRE WAS ATTEMPTED TO BE SHAPED PRIOR TO USE, BUT THE TIP COIL BECAME STRETCHED THE BLACK COATING PEELED FROM THE TIP. ANOTHER PILOT 50 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977691 ↗
• MalfunctionMay 5, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING OF THE PILOT GUIDE WIRE, THE PHYSICIAN WIPED THE WIRE AND SOME KIND OF MATERIAL WAS NOTED ON THEIR GLOVES. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER PILOT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960514 ↗
• InjuryNov 11, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A HI-TORQUE PILOT GUIDEWIRE (GW) WAS ADVANCED THROUGH THE LESION AND USED DURING THE PROCEDURE; HOWEVER, DURING RETRACTION, RESISTANCE WITH THE GUIDING CATHETER WAS FELT THEREFORE FORCE WAS APPLIED. IT WAS NOTED THAT THE GUIDING SUPPORT POSITION DEVIATED CAUSING THE GW TO SEPARATE AT THE TIP. THE SEPARATED PIECE WAS RETRIEVED USING OTHER GUIDE WIRES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652973 ↗
• InjuryAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE HT PILOT GUIDEWIRE CROSSED THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY WITHOUT RESISTANCE, BUT PART OF THE SHAFT AND THE RADIOPAQUE TIP OF THE GUIDE WIRE SEPARATED IN THE RCA. THE SEPARATED SEGMENT TRAVELED TO THE DISTAL PORTION OF THE LESION IN THE RCA. ATTEMPTS TO REMOVE THE SEPARATED SEGMENT WERE MADE, BUT NOT SUCCESSFUL. ANOTHER PILOT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN IMPLANTED ONE LONG STENT TO EMBED THE SEPARATED PORTION OF THE WIRE INTO THE VESSEL WALL AND ALSO TO TREAT THE TARGET LESION. THE PATIENT WAS ADMITTED TO THE CARDIAC INTENSIVE CARE UNIT AND WAS DISCHARGED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19942334 ↗
• InjuryAug 8, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE HT PILOT GUIDE WIRE SEPARATED AT THE LOCATION OF INTRAVASCULAR THROMBUS. THE CORRECTED LOT NUMBER FOR THIS DEVICE IS 3110971. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941505 ↗
• 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 ↗
• MalfunctionApr 1, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE HI TORQUE PILOT GUIDE WIRE WAS OPENED, THE DISTAL PORTION OF THE GUIDE WIRE COATING WAS NOTED TO BE INSUFFICIENT AS IT WAS MISSING FROM THE DEVICE. THEREFORE, THE GUIDE WIRE WAS NOT 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 19015725 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), AFTER THE BALLOON CROSSED THE HEAVILY CALCIFIED RCA, THE PHYSICIAN NOTED THERE WERE SOME UNKNOWN FLOW ISSUES, POSSIBLY DUE TO THE RUNTHROUGH OR PILOT WIRE GUIDE WIRES, WHILE REWIRING THE ARTERY AFTER SUBINTIMAL. SURGERY WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18684670 ↗
• 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 ↗

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