SPARTACORE 1005206Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648014062), received between Jun 9, 2020 and Jan 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE DISTAL POPLITEAL ARTERY TIBIOPERONEAL (TP) TRUNK. A 300CM HI-TORQUE SPARTACORE 14 GUIDEWIRE (GW) WAS ADVANCED TOWARDS THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY, AND MADE IT TO THE DISTAL POPLITEAL; HOWEVER, IT COULD NOT CROSS THE LESION. THE GW WAS THEN REMOVED AND IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE WAS STRETCHED AND LOOKED LIKE IT HAD BEEN TORQUED AROUND. THE COILS MAY HAVE BEEN PULLED APART [SLIGHTLY UNRAVELED]. NO PART OF THE WIRE WAS SEPARATED AND THE WIRE WAS REMOVED INTACT. A COMMAND 18 WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21278154 ↗
• MalfunctionMar 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE HI-TORQUE (HT) SPARTACORE GUIDE WIRE WAS USED SUCCESSFULLY, HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE WAS EXPIRED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542035 ↗
• MalfunctionApr 26, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO A LESION WITH MILD CALCIFICATION BETWEEN THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA). THE SUPERA PERIPHERAL STENT SYSTEM WAS ADVANCED OVER THE SPARTA CORE GUIDE WIRE WITHOUT ISSUE AND THE STENT WAS DEPLOYED SUCCESSFULLY. DURING REMOVAL OF THE SUPERA, THE DEVICE BECAME STUCK WITH THE GUIDE WIRE AND COULD NOT BE REMOVED. THEREFORE, BOTH DEVICES HAD TO BE REMOVED AS ONE SINGLE UNIT. A NEW COMMAND GUIDE WAS ADVANCED, AND A SECOND STENT WAS DEPLOYED WITHOUT COMPLICATIONS. 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 11724951 ↗
• InjuryJun 9, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A SPARTACORE GUIDE WIRE WAS BEING ADVANCED WHEN RESISTANCE WITH THE ANATOMY WAS NOTED AND THE TIP BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVED THE SEPARATED TIP VIA SNARE AND SUCCESSFULLY USED ANOTHER WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135842 ↗