HI-TORQUE COMMAND 1013730Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648212123), received between Dec 20, 2018 and Aug 28, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HI-TORQUE (HT) COMMAND 18 ST GUIDEWIRE WAS ADVANCED WITHOUT ISSUES; HOWEVER, UPON REMOVAL GOT STUCK WITH A MICRO DILATOR AND WAS REMOVED AS A SINGLE UNIT. THE GUIDEWIRE WAS NOTED TO HAVE THE POLYMER SEPARATED BUT REMAINS ON THE THE DEVICE AND NOTHING REMAINED IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT 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 22910199 ↗
• MalfunctionNov 7, 2024Difficult to Remove; Difficult to Remove

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634751 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE COMMAND 18 GUIDE WIRE WAS INSERTED INTO A NON-ABBOTT 6FR GUIDING CATHETER VIA AN ANTEGRADE APPROACH FROM THE RIGHT COMMON FEMORAL ARTERY (CFA). RESISTANCE WAS NOTED DURING ADVANCEMENT WITH THE GUIDING CATHETER AND TWO SHORT PIECES OF POLYMER WERE STUCK TO THE INSERTION SITE OF THE GUIDING CATHETER. SUBSEQUENTLY, WHEN THE GUIDE WIRE WAS REMOVED VIA A RETROGRADE APPROACH FROM THE RIGHT CFA, THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND ONE LONG PIECE OF POLYMER JACKET CAME OUT. NO POLYMER WAS REMOVED FROM THE PATIENT AND NOTHING REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695127 ↗
• MalfunctionDec 20, 2022Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT AN OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE HT COMMAND 18 GUIDEWIRE (GW) WAS ADVANCED THROUGH THE 6FR SHORT SHEATH SHEATH, BUT MET HEAVY RESISTANCE, SO IT WAS REMOVED FROM THE ANATOMY. OUTSIDE THE ANATOMY, THE COATING OF THE TIP OF THE GW WAS NOTED TO BE PEELING OFF. NO PART OF THE PEELED MATERIAL WAS IN THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019223 ↗
• InjuryJan 6, 2022Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC AND RENAL ARTERIES. THE ILIAC WAS TREATED FIRST WITH THE COMMAND 18 (210 CM) GUIDE WIRE AND IT WAS NEXT USED TO TREAT THE RIGHT AND LEFT OCCLUDED RENAL ARTERIES. THE COMMAND 18 (210 CM) WAS USED WITH INTRAVASCULAR ULTRASOUND (IVUS) HOWEVER THERE WAS RESISTANCE WITH THE IVUS DURING CROSSING THE OCCLUDED LESION. THE GUIDE WIRE WAS CONTINUED TO BE USED AND THERE WAS RESISTANCE DURING REMOVAL. NEXT, THE COMMAND 18 (210 CM) GUIDE WIRE AND IVUS WERE CHANGED TO A NEW COMMAND 18 (300 CM) AND A NEW IVUS; HOWEVER, AGAIN THERE WAS RESISTANCE WITH THE IVUS DURING CROSSING THE OCCLUDED LESION. THE NEW IVUS BECAME STUCK WITH THE COMMAND 18 (300 CM) AND IT WAS ATTEMPTED TO REMOVE THE IVUS. DURING THIS ATTEMPT, THE COMMAND 18 (300 CM) PERFORATED THE VESSEL WHEN THE IVUS WAS PULLED STRONGLY. ALL DEVICES WERE THEN REMOVED AND A NEW COMMAND 14 GUIDE WIRE WAS USED AND A BALLOON WAS USED TO DILATE THE LESION AND A STENT WAS PLACED. THE PERFORATION WAS THEN TREATED BY OCCLUSION USING COIL AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN STATED THAT THE COMMAND 18 (210 CM) POSSIBLY HAD PEELING OR UNEVEN COATING. BOTH OF THE COMMAND 18 GUIDE WIRES (3

  Patient problems: Foreign Body In Patient

  MAUDE report 13181693 ↗
• InjurySep 28, 2021Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, ACCESS WAS GAINED VIA PEDAL APPROACH AND THE 10CM HT COMMAND 18 GUIDE WIRE (GW) WAS ADVANCED, WHEN THE TIP OF THE GW BECAME STUCK IN A PREVIOUSLY IMPLANTED STENT THAT THE PHYSICIAN WAS UNAWARE WAS IMPLANTED. DURING AN ATTEMPT TO REMOVE THE GW, THE TIP BECAME SEPARATED IN THE ANATOMY. AN ATTEMPT TO SNARE THE SEPARATED TIP WAS UNSUCCESSFUL SO THEY DECIDED TO ADVANCE ANOTHER STENT AND EMBED THE SEPARATED TIP WITH THE PREVIOUS IMPLANTED STENT. THE FINAL PATIENT OUTCOME WAS GOOD, NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12543745 ↗
• MalfunctionApr 9, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, MODERATELY TORTUOUS CHEST CANAL. THE HI-TORQUE COMMAND 18 GUIDEWIRE ADVANCED WITHOUT ISSUE THEN BECAME STUCK INSIDE A NON-ABBOTT 2.0F MICROCATHETER. FORCE WAS APPLIED TO REMOVE THE WIRE FROM THE CATHETER. AN UNSPECIFIED GUIDEWIRE 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.

  Patient problems: Insufficient Information

  MAUDE report 11642412 ↗
• MalfunctionDec 20, 2018Off-Label Use; Material Split, Cut or Torn; Off-Label Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE TORTUOUS RIGHT DORSALIS PEDIS ARTERY. AN ATHERECTOMY DEVICE WAS USED OVER THE COMMAND GUIDE WIRE AND THE POLYMER WAS TORN AWAY FROM THE CORE. THE GUIDE WIRE WAS SAFELY WITHDRAWN THROUGH THE GUIDE CATHETER UNDER FLUOROSCOPY. A NEW COMMAND GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND 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 8184285 ↗