HI-TORQUE PILOT 1010482-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648073892), received between Apr 2, 2018 and Nov 20, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 28, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH HEAVY CALCIFICATION. THE 014 HI-TORQUE PILOT 200 GUIDEWIRE (GW) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE TIP OF THE GW BROKE OFF IN THE ABDOMINAL AORTA. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A SNARE DEVICE FOR 90 MINUTES TO RETRIEVE THE TIP OF THE GW. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415981 ↗
• MalfunctionDec 15, 2020Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) WITH 100% STENOSIS. THE PILOT 200 GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THE GUIDE WIRE WAS REMOVED AND RESHAPED TO A KNUCKLE SHAPE AND AGAIN THE GUIDE WIRE COULD NOT CROSS. DURING REMOVAL THERE WAS RESISTANCE AND THE TIP BECAME WAVY AND THE COILS WERE STRETCHED. IT WAS CONFIRMED BY THE ACCOUNT THAT THERE WAS NO SEPARATION OR BREAK. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE AND BALLOON DILATATION WAS PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11009079 ↗
• MalfunctionMar 30, 2020Break; Failure to Advance; Deformation Due to Compressive Stress; Break; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A MID-RIGHT CORONARY ARTERY (RCA), HEAVILY CALCIFIED LESION. THE PILOT GUIDEWIRE FAILED TO ADVANCE THE LESION. AFTER SEVERAL ADVANCEMENTS ATTEMPTS AND ADDED TORQUE, THE TIP BECAME FLOPPY. ANOTHER UNSPECIFIED GUIDEWIRE WAS USED, HOWEVER, THIS GUIDEWIRE ALSO FAILED TO CROSS THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900395 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). MULTIPLE GUIDE WIRES WERE ATTEMPTED TO CROSS, INCLUDING A WHISPER EXTRA SUPPORT AND PILOT 50 GUIDE WIRE, BUT WERE UNABLE TO CROSS THE CHRONIC TOTAL OCCLUSION. A PILOT 200 GUIDE WIRE WAS SUCCESSFUL IN CROSSING OVER USING A MINI SUPPORT CATHETER. THE PILOT GUIDE WIRE APPEARED TO BE IN THE TRUE VESSEL LUMEN, BUT THE SUPPORT CATHETER WAS UNABLE TO ADVANCE FURTHER. THE SUPPORT CATHETER WAS EXCHANGED FOR A SPIRAL CATHETER, WHICH WAS ABLE TO BE ADVANCED TO THE MID RCA. ANGIOPLASTY WAS PERFORMED IN THE MID RCA WITH A 1.2X12 AND A 1.5X20 MM TREK, BUT THESE COULD NOT BE ADVANCED PAST THE MID RCA. THERE WAS NO SIGNIFICANT CHANGE IN BLOOD FLOW AND A DISSECTION WAS NOTED IN THE DISTAL RCA. THE PROCEDURE WAS COMPLETED. NO TREATMENT WAS GIVEN FOR THE DISSECTION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS ASYMPTOMATIC THROUGH OUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8527478 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. AFTER PLACEMENT OF A 014 HI-TORQUE PILOT GUIDE WIRE, AN ATTEMPT WAS MADE TO ADVANCE A 2.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS). THE SDS FAILED TO CROSS DUE TO THE ANATOMY AND WAS REMOVED WITHOUT ISSUES. A DISSECTION CAUSED BY THE GUIDE WIRE WAS NOTED IN THE DISTAL CX. MEDICAL MANAGEMENT WAS PROVIDED AND THE PATIENT WAS IN OBSERVATION. THERE ARE FUTURE PLANS TO BRING THE PATIENT BACK TO THE CATHETER LAB FOR STENTING. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7843617 ↗
• MalfunctionApr 2, 2018Peeled/Delaminated; Difficult To Position

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, 99% STENOSED, DISTAL RIGHT CORONARY ARTERY (RCA) TWO DIFFERENT NON-ABBOTT GUIDE WIRES (GW) WERE USED SEPARATELY BUT FAILED TO CROSS THE LESION. A PILOT GW WAS USED BUT MET RESISTANCE INSIDE THE GUIDE CATHETER AND WAS REMOVED; OUTSIDE THE ANATOMY PEELING OF THE COATING WAS SUSPECTED. A DIFFERENT GW WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED ISSUE. 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 7388657 ↗