SPARTACORE 1005202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648014024), received between Dec 17, 2019 and Sep 19, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionSep 19, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION A 190CM HI-TORQUE SPARTACORE GUIDEWIRE (GW) WAS REMOVED FROM ITS PACKAGED, WHEN IT WAS NOTED TO HAVE BLUE, FUZZY BUMP ON THE WIRE NEAR THE TIP. THE DEVICE WAS REPLACED WITH ANOTHER SPARTACORE GW AND THE PROCEDURE WAS COMPLETED THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255680 ↗
• MalfunctionJan 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS PROXIMAL POPLITEAL ARTERY NEAR THE TP (TIBIOPERONEAL) TRUNK. A NON-ABBOTT LASER CATHETER WAS ADVANCED OVER THE SPARTACORE GUIDE WIRE WITHOUT ANY RESISTANCE. UPON REMOVAL OF THE CATHETER, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SPARTACORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466714 ↗
• InjuryApr 12, 2021Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 6X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM WAS ADVANCED OVER A SUPRACORE GUIDEWIRE AND THE STENT WAS IMPLANTED WITHOUT ISSUE. A NON-ABBOTT GUIDING CATHETER WAS THEN USED TO REMOVE THE SUPRACORE WIRE, THEN A 0.014 HI-TORQUE SPARTACORE WIRE WAS ADVANCED THROUGH THE SAME CATHETER AND ATTEMPTED TO BE PLACED BUT THE WIRE GOT CAUGHT WITH THE IMPLANTED STENT. THE STENT PULLED BACK WITH THE WIRE AND LOOKED LIKE IT WAS GOING TO FRACTURE, BUT WHEN THE WIRE UNFURLED THE STENT SETTLED BACK INTO PLACE. A CUT DOWN WAS DONE TO REMOVE THE WIRE. THE WIRE WAS CUT BY THE PHYSICIAN TO REMOVE ANYTHING BEYOND THE STENT PROXIMALLY. THE PORTION WITHIN THE STENT REMAINS EMBEDDED IN THE VESSEL. THERE WAS NO DAMAGE TO THE STENT, AND IT REMAINS IMPLANTED IN THE TARGET LESION. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11651202 ↗
• MalfunctionOct 1, 2020Break; Peeled/Delaminated; Stretched; Break; Peeled/Delaminated; Stretched

  IT WAS REPORTED THAT THE COATING OF THE HI-TORQUE SPARTACORE 14 GUIDE WIRE CAME OFF. A PHOTO RECEIVED FROM THE ACCOUNT TO SHOW THE MALFUNCTION CONFIRMS THE COILS WERE STRETCHED AND POSSIBLY UNRAVELED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617730 ↗
• InjuryDec 17, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND TIBIAL ARTERY. A SPARTACORE GUIDE WIRE TIP WAS PLACED IN A SMALL PERIPHERAL FEEDER BRANCH, LOCATED AT THE BIFURCATION OF THE POSTERIOR AND ANTERIOR TIBIAL ARTERY. DURING GUIDE WIRE RE-POSITIONING, THE WIRE TIP BECAME STUCK IN THIS SMALL SIDE BRANCH. SEVERAL ATTEMPTS TO REMOVE THIS WIRE WERE PERFORMED AND THE GUIDE WIRE TIP HAD SEPARATED. THE SEPARATED TIP REMAINS IN THE PATIENT'S ANATOMY. THERE WAS NO TREATMENT PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9482076 ↗