HI-TORQUE COMMAND 2078174Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648176678), received between Sep 1, 2016 and Jun 25, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS FOR A LOWER LIMB ANGIOGRAM. WHEN TRYING TO CATHETERIZE THE TIBIAL ARTERY, THE HT COMMAND GUIDE WIRE WENT INTO A COLLATERAL ARTERY. WHEN THE GUIDE WIRE WAS REMOVED, IT WAS NOTED THAT THE DISTAL PART HAD SEPARATED AND REMAINED IN THE PATIENT. ATTEMPTS WERE MADE TO SNARE THE SEPARATED PORTION HOWEVER WERE UNSUCCESSFUL AND THE SEPARATED PORTION REMAINS FREE FLOATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19603986 ↗
• MalfunctionMar 9, 2023Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE SEPARATED PORTION OF THE GUIDE WIRE WAS IN THE IVUS CATHETER AND WAS REMOVED WITH THE IVUS CATHETER. RETURN DEVICE ANALYSIS FOUND THERE WAS CORROSION ON THE DISTAL SOLDER AND ON THE DISTAL COILS; HOWEVER, THE ACCOUNT REPORTED THAT THEY WERE NOT AWARE OF THE CORROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518573 ↗
• MalfunctionFeb 16, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. A .014 HT COMMAND GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND A NON-ABBOTT INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED OVER THE COMMAND GUIDE WIRE. DURING REMOVAL OF THE COMMAND GW FOR RE-SHAPING, RESISTANCE WAS MET, SO BOTH THE COMMAND GW AND IVUS CATHETER WERE REMOVED TOGETHER, AS A SINGLE UNIT. WHILE TRYING TO RE-SHAPE THE COMMAND GW OUTSIDE OF THE ANATOMY, THE TIP OF THE GUIDE WIRE SEPARATED. A NEW GW AND IVUS CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392746 ↗
• MalfunctionSep 30, 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 A HEAVILY CALCIFIED TIBIAL ARTERY THAT IS 90% STENOSED. THE 014 HT COMMAND GUIDE WIRE CROSSED LESION SUCCESSFULLY. THE 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED AND USED TO PRE-DILATE THE LESION SUCCESSFULLY EVEN THOUGH RESISTANCE WAS MET DURING ADVANCEMENT WITH THE GUIDE WIRE. ONCE REMOVED THE 4.0X38MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ATTEMPTED TO ADVANCE OVER THE WIRE; HOWEVER, RESISTANCE WAS MET WITH THE GUIDE WIRE. THE SAME ARMADA 14 BALLOON WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE, BUT MET RESISTANCE WAS NOTED AGAIN. THE BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER. THE GUIDE WIRE WAS REMOVED AND THE COATING WAS NOTED TO BE PEELED BUT REMAINING ON THE GUIDE WIRE. ANOTHER COMMAND GUIDE WIRE AND XIENCE PRIME WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510533 ↗
• MalfunctionMay 9, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 14 HT COMMAND GUIDE WIRE BECAME DAMAGED DURING THE PROCEDURE. ANOTHER 014 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. PER DEVICE ANALYSIS THE POLYMER COATING WAS SEPARATED (NOT IN TWO PIECES) 12MM PROXIMAL TO THE DISTAL TIP. THE POLYMER AT THE SEPARATION WAS TORN, BUNCHED AND JAGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338014 ↗
• InjuryMar 8, 2021Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION BEHIND THE KNEE (BTK) WITH TOTAL OCCLUSION. THE COMMAND GUIDE WIRE (GW) WAS ADVANCED TO THE LESION WITH THE SUPPORT OF A 2.0X80MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER; HOWEVER, THE GW COULD NOT CROSS AND BECAME STUCK IN THE OCCLUSION AFTER ATTEMPTING TO GO FURTHER SUBINTIMAL. THE TIP OF THE COMMAND GW SEPARATED IN THE ANTERIOR TIBIAL ARTERY AND NO ATTEMPT WAS MADE TO RETRIEVE THE TIP. THE ARMADA 14 WAS INFLATED TO A MAXIMUM OF 7 ATMOSPHERES. NO RUPTURE NOTED, BUT A TEAR IN THE TIP OF THE ARMADA 14 FROM THE TIP TO THE BEGINNING OF THE BALLOON WAS NOTED AND WAS DUE TO BEING ADVANCED WITH THE COMMAND GUIDE WIRE IN THE HEAVILY CALCIFIED LESION. A WINN GUIDE WIRE WAS ABLE TO CROSS THE LESION BUT NO OTHER DEVICE, INCLUDING A 2.0X120 MM ARMADA, A 2.0X20 MM ARMADA XT AND A NON-ABBOTT BALLOON WAS ABLE TO CROSS DESPITE THE USE OF A NON-ABBOTT LONG INTRODUCER SHEATH. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11440226 ↗
• MalfunctionNov 26, 2020Difficult to Remove; Difficult to Remove

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS REPORTED: RESISTANCE WAS NOTED DURING REMOVAL OF THE COMMAND GUIDE WIRES WITH THE GUIDELINERS. DURING USE OF THE SPARTACORE GUIDE WIRE, THE TIP SEPARATED. IT WAS SUCCESSFULLY REMOVED USING A SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10908306 ↗
• MalfunctionNov 26, 2020Difficult to Remove; Difficult to Remove

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS REPORTED: RESISTANCE WAS NOTED DURING REMOVAL OF THE COMMAND GUIDE WIRES WITH THE GUIDELINERS. DURING USE OF THE SPARTACORE GUIDE WIRE, THE TIP SEPARATED. IT WAS SUCCESSFULLY REMOVED USING A SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10908261 ↗
• MalfunctionJul 29, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RENAL ARTERY. A 5X20MM VIATRAC PLUS BALLOON WAS PLACED OVER A HI-TORQUE COMMAND GUIDE WIRE, AND RESISTANCE WAS MET WHEN ADVANCING THE BALLOON OVER THE WIRE. THEREFORE, IT WAS DECIDED TO REMOVE THE BALLOON, BUT FORCE HAD TO BE APPLIED AS RESISTANCE WAS MET, AND THE BALLOON PORTION SEPARATED. THE DEVICES WERE SIMPLY REMOVED ALTOGETHER AND IT WAS CONFIRMED THAT NOTHING REMAINED IN THE ANATOMY. ANOTHER BALLOON AND GUIDE WIRE WERE 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. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT CONFIRMING THAT THE SHAFT SEPARATED, NOT THE BALLOON PORTION AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337834 ↗
• InjuryJan 31, 2020Difficult to Remove; Material Separation; Difficult to Advance; Material Too Soft/Flexible; Difficult to Remove; Material Separation; Difficult to Advance; Material Too Soft/Flexible

  ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE TORTUOUS ANTERIOR TIBIAL ARTERY. RESISTANCE WAS NOTED WITH THE ANATOMY AND GUIDING CATHETER DURING ADVANCEMENT, AND RESISTANCE WITH THE ANATOMY WAS NOTED DURING WITHDRAWAL. THE GUIDE WIRE WAS PROLAPSED UNTIL IT REACHED THE OCCLUSION. THE TIP WAS NOT REMOVED AND A PORTION REMAINS STUCK IN THE VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 9653590 ↗
• MalfunctionApr 10, 2019Failure to Advance; Difficult to Advance; Material Split, Cut or Torn; Failure to Advance; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NON-TORTUOUS, ECCENTRIC, MID ANTERIOR TIBIAL ARTERY, THE COMMAND WIRE TRANSITION COULD NOT ADVANCE PASS A CERTAIN SECTION OF THE NON-ABBOTT GUIDE CATHETER. EACH DEVICE WAS REMOVED SEPARATELY FROM THE ANATOMY WITHOUT REPORTED ISSUE. A DIFFERENT NON-ABBOTT GUIDE WIRE WAS ATTEMPTED WITH THE SAME OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. *RETURNED DEVICE ANALYSIS REVEALED THE POLYMER COATING ON THE TIP WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500696 ↗
• MalfunctionSep 1, 2016Physical Property Issue; Torn Material

  IT WAS REPORTED THAT THE 190 CM HT COMMAND GUIDE WIRE WAS UNPACKED AND FLUSHED WITH SALINE WITHOUT ISSUE. PRIOR TO INSERTION INTO THE PATIENT ANATOMY, A PORTION OF THE TIP WAS NOTICED TO BE UNCOATED. THE GUIDE WIRE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER GUIDE WIRE AND THE PATIENT IS DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE POLYMER COATING ON THE GUIDE WIRE WAS TORN.

  Patient problems: No Patient Involvement

  MAUDE report 5922358 ↗