HI-TORQUE COMMAND 2078172Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648176654), received between Feb 22, 2017 and Dec 18, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TOTALLY OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE COMMAND 190 GUIDE WIRE WAS ADVANCED WITH A PENETRATION CATHETER HOWEVER THE CATHETER BECAME STUCK. THE GUIDE WIRE WAS REMOVED AND REPLACED WITH A COMMAND 250; HOWEVER RESISTANCE WAS FELT DURING ADVANCEMENT AND RETRACTION WITH THE PENETRATION CATHETER. THE GUIDE WIRE WAS REMOVED LEAVING THE CATHETER IN PLACE AND THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837976 ↗
• MalfunctionMay 19, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE COMMAND GUIDE WIRE REACHED THE LESION WHEN IT WAS NOTED THE TIP COATING MIGHT HAVE FLARED [PEELED]. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. 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 22045966 ↗
• MalfunctionJan 2, 2025Material Too Rigid or Stiff; Material Separation; Material Split, Cut or Torn; Material Too Rigid or Stiff; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH THE 190CM HT COMMAND 14 GUIDE WIRE (GW). THE TIP FELT STIFFER THAN A USUAL; HOWEVER, THE GW WAS ADVANCED INTO THE PATIENT ANATOMY. AFTER THE LESION WAS CROSSED USING A NON-ABBOTT GUIDING CATHETER, THE COMMAND GW WAS EXCHANGED FOR A NON-ABBOTT 300CM GW DUE TO NEEDING A LONGER SIZE. AFTER WITHDRAWAL, THE TIP LOAD WAS AGAIN INSPECTED AND NOTED TO FEEL SIGNIFICANTLY STIFFER THAN USUAL. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A SEPARATION OF THE DISTAL CORE, POLYMER COATING, COILS, AND DISTAL SOLDER TIP. ADDITIONAL INFORMATION RECEIVED FROM THE SITE INDICATED THAT NO PORTION OF THE SEPARATED DEVICE REMAINED IN THE PATIENT ANATOMY; HOWEVER, IT WAS UNKNOWN WHEN THE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063472 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A PERIPHERAL EMBOLIZATION WAS NOTED DURING THE PROCEDURE. THE EMBOLIZATION WAS REPORTEDLY, NOT CLINICALLY IMPORTANT. NO TREATMENT WAS PROVIDED, AND THE ISSUE RESOLVED. IT IS UNKNOWN IF THE HT COMMAND GUIDEWIRE WAS IN THE PATIENT WHEN THE EMBOLIZATION WAS NOTED IN THE PERONEAL ARTERY. IN THE PHYSICIAN¿S OPINION, IT IS UNKNOWN IF AN ABBOTT DEVICE CAUSED OR CONTRIBUTE TO THE NOTED EMBOLIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 17419330 ↗
• MalfunctionSep 27, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE HT COMMAND 14 GUIDEWIRE WAS REMOVED FROM THE PACKAGE, A CHIP IN THE TEFLON WAS NOTED. IT WAS THOUGHT THAT THE TEFLON COATING WAS CHIPPED PRIOR TO REMOVAL OF THE DEVICE FROM THE PACKAGING. THEREFORE, THE GUIDEWIRE WAS NOT USED IN THE PATIENT ANATOMY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HT COMMAND 14 GUIDEWIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491620 ↗
• MalfunctionSep 15, 2021Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, NON-TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. A NON-ABBOTT GUIDING SHEATH AND NON-ABBOTT INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WERE USED WITH A COMMAND 14 GUIDE WIRE. THE GUIDE WIRE AND IVUS FACED RESISTANCE DURING ADVANCEMENT AND BECAME STUCK TOGETHER, AND THE GUIDE WIRE CORE BECAME KINKED. THE DEVICES WERE REMOVED TOGETHER, AND A NEW COMMAND 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474853 ↗
• InjurySep 4, 2019Off-Label Use; Material Separation; Difficult to Advance; Off-Label Use; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED INTERNAL SHUNT LOCATED IN THE ANTEBRACHIUM. A HI-TORQUE COMMAND 14 GUIDE WIRE (GW) CROSSED THE LESION. A NON-ABBOTT BALLOON WAS ADVANCED OVER THE COMMAND GW HOWEVER, IT FAILED TO CROSS DUE TO RESISTANCE WITH THE GW. THE COMMAND GW WAS THEN REMOVED. ONCE REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE GW HAD BECOME SEPARATED ABOUT 20CM FROM THE DISTAL END (CORE). THE SEPARATED PORTION REMAINED IN THE ANATOMY BUT WAS ULTIMATELY RETRIEVED VIA A SNARE DEVICE. THEN A V-18 GW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960642 ↗
• InjuryJun 23, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION LOCATED BELOW THE KNEE. A NON-ABBOTT ATHERECTOMY CATHETER CROSSED THE LESION AND THEN A 190 CM HT COMMAND GUIDE WIRE WAS ADVANCED THROUGH THE ATHERECTOMY CATHETER UP TO THE LESION. THEN THE GUIDE WIRE MET RESISTANCE WITH A NON-ABBOTT BALLOON CATHETER WHEN THE CATHETER WAS BEING ADVANCED TO THE LESION. THUS BOTH DEVICES WERE REMOVED FROM THE ANATOMY AND PART OF THE GUIDE WIRE WAS FOUND TO BE SEPARATED INSIDE THE ANATOMY. IT IS UNKNOWN HOW THE SEPARATED PORTION OF THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664755 ↗
• MalfunctionFeb 22, 2017Kinked; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION. AN HT COMMAND GUIDE WIRE WAS ADVANCED TO THE LESION; HOWEVER, IT FAILED TO CROSS DUE TO THE ANATOMY. AFTER SEVERAL ATTEMPTS TO CROSS THE TIP BECAME WEAK AND BENT. THERE WAS RESISTANCE REMOVING THE DEVICE. ANOTHER UNKNOWN GUIDE WIRE WAS ADVANCED; HOWEVER, THIS TOO FAILED TO CROSS AND THE PROCEDURE WAS ABORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6351567 ↗