HI-TORQUE COMMAND™ 1060002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648356841), received between Feb 13, 2025 and Aug 18, 2026 — classified as 5 malfunctions.

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

• MalfunctionAug 18, 2026Difficult to Remove; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299850 ↗
• MalfunctionMar 2, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT HAD AN OCCLUSION IN THE PEDAL AREA. THE HT COMMAND 14 ST 300 WAS ADVANCED TO DORSALIS PEDIS ARTERY, AND THE WIRE CROSSED THE OCCLUSION. A NON-ABBOTT 2.5 X 200 MM BALLOON DILATATION CATHETER WAS ADVANCED OVER THE COMMAND WIRE UNTIL IT REACHED 3-4 CM BEFORE THE TIP OF THE WIRE. AT THIS POINT THE PHYSICIAN FELT RESISTANCE AND HAD DIFFICULTY IN MANEUVERING THE WIRE. THE COMMAND WIRE WAS EXCHANGED FOR A NON-ABBOTT GUIDE WIRE WITH NO PROBLEM. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WERE NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE WAS BROKEN AT THE DISTAL SOLDER BALL. THE CUSTOMER BELIEVES THAT THE OBSERVED DAMAGE OCCURRED DURING THE PROCEDURE AND THIS WAS CAUSING THE RESISTANCE FELT DURING ADVANCEMENT. IT WAS THOUGHT THAT IT WAS SOMEHOW CAUSED BY THE INTERACTION BETWEEN THE COMMAND WIRE AND THE 2.5 X 200 MM NON-ABBOTT BALLOON DILATATION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489858 ↗
• MalfunctionNov 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A NARROW LESION IN THE POSTERIOR TIBIAL ARTERY. A NON-ABBOTT DEVICE WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. A HT COMMAND 14 GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION. DURING REMOVAL THE GUIDE WIRE BECAME STUCK IN THE VESSEL THEREFORE THE SHEATH WAS ADVANCED TO REMOVE THE GUIDE WIRE. SEVERAL OTHER GUIDE WIRES INCLUDING A SPARTACORE GUIDE WIRE WERE ADVANCED HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. AN ESPRIT BTK WAS SUCCESSFULLY USED TO 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 23485088 ↗
• MalfunctionJun 17, 2025Break; Difficult to Advance; Material Too Soft/Flexible; Break; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND CHRONICALLY OCCLUDED LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE COMMAND 14 ST GUIDE WIRE WAS ADVANCED WITH DIFFICULTY DUE TO THE ANATOMY. AFTER APPROXIMATELY 30 MINUTES ADVANCING, THE GUIDE WIRE TIP DID A VERY TINY LOOP. THE PHYSICIAN FORCED THE WIRE TO STRAIGHTEN BY PULLING IT INTO THE ARMADA 14 CATHETER. THE TIP COILS STRETCHED OUT AT THE LOOP SECTION AND THE CORE SEPARATED BUT THE GUIDE WIRE WAS STILL IN ONE PIECE. THE GUIDE WIRE WENT INTO THE ARMADA14 XT GUIDEWIRE LUMEN AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. 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 22226806 ↗
• MalfunctionFeb 13, 2025Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY. A 300CM GUIDEWIRE (GW) WAS SUCCESSFULLY USED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA); HOWEVER, AFTER THE GW WAS REMOVED THE PHYSICIAN NOTICED THE TIP OF THE WIRE TO APPEAR TO HAVE LESS COATING AND SHINNY AS IF THE COATING OF THE TIP WAS BRUSHED OFF FROM THE TIP OF THE WIRE. IMAGES WERE TAKEN AND SENT TO THE GLOBAL ENGINEERING AND MARKETING TEAMS, IN WHICH IT WAS DETERMINED THAT NO POLYMER WAS REMOVED AND THE NOTED SHINNY WIRE IS SIMPLY HOW THE DEVICE WAS DESIGNED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY REPORTED EVENT, THE DEVICE WAS RECEIVED AND THE ANALYSIS REVEALED THAT THE COILS WERE STRETCHED AND THE POLYMER COATING WAS TORN. THE ACCOUNT WAS NOT AWARE OF REPORTED ISSUES FOUND BY QAT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380128 ↗