HI-TORQUE VERSACORE 1012068-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648124150), received between May 7, 2018 and May 22, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2018Break; Device Operates Differently Than Expected

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT RADIAL ARTERY. IT WAS NOTED AFTER THE FIRST CATHETER EXCHANGE THAT THE WHITE JACKET OF THE VERSACORE GUIDE WIRE KEPT MOVING. A NEW VERSACORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. RETURN DEVICE ANALYSIS NOTED THE DISTAL END OF THE WHITE JACKET WAS SEPARATED AT THE PROXIMAL END OF THE TEFLON COATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7534244 ↗
• InjuryMay 7, 2018Entrapment of Device; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE DIAGNOSTIC PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE RIGHT RADIAL ARTERY. A 145 CM HT VERSACORE GUIDE WIRE WAS INSERTED INTO THE RIGHT ARM OF THE PATIENT, AND AFTER GAINING RADIAL ACCESS, THE WIRE ADVANCED TO THE AORTIC ARCH TO TAKE IMAGES. AN UNSPECIFIED BALLOON CATHETER THAT WAS ADVANCED OVER THE GUIDE WIRE WAS REMOVED AND ANOTHER UNSPECIFIED CATHETER WAS INSERTED. RESISTANCE MET WITH THE GUIDE WIRE AND THE BALLOON CATHETER COULD NOT ADVANCE AND IT WAS REMOVED, BUT THE GUIDE WIRE COULD NOT MOVE FORWARD OR RETRACT. FLUOROSCOPY SHOWED THE GUIDE WIRE LOOKED STRETCHED. THE GUIDE WIRE REMAINED EMBEDDED IN THE VESSEL WHILE A FEMORAL APPROACH WAS USED TO COMPLETE THE REST OF THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM FOR A SURGICAL CUT DOWN. AN INCISION WAS MADE IN THE PATIENT'S ARM, AND A DECISION WAS MADE TO BREAK THE WIRE TO REMOVE 8.7 CM OF THE WIRE FROM THE ARTERY. THE PATIENT WAS THEN SENT TO SURGICAL PATHOLOGY FOR ANOTHER SURGICAL CUT DOWN, AND THE REMAINDER OF THE WIRE WAS REMOVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492679 ↗