HI-TORQUE VERSACORE 1012068-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648124204), received between Mar 25, 2020 and Jul 8, 2024 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILLIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7X80MM ABSOLUTE PRO SELF EXPANDING STENT WAS ADVANCED OVER A 0.035 HI-TORQUE VERSACORE FLOPPY GUIDE WIRE WITHOUT RESISTANCE. THE THUMBWHEEL WAS ENGAGED AND THE STENT DEPLOYED WITHOUT ISSUES. UPON WITHDRAWAL, RESISTANCE WAS FELT WITH THE GUIDE WIRE. SALINE WAS FLUSHED THROUGH THE ABSOLUTE PRO DELIVERY SYSTEM USING THE HYDROPLANE TECHNIQUE, IN ORDER TO SLIDE THE ABSOLUTE PRO DELIVERY SYSTEM OFF THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND PROXIMAL PORTION OF THE WIRE WAS NOTED TO BE BENT YET REMAINED INTACT. 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 19690704 ↗
• MalfunctionAug 28, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MESENTERIC ARTERY. THE VERSACORE GUIDE WIRE COULD NOT BE REMOVED FROM AN UNSPECIFIED BALLOON CATHETER. THE DEVICES WERE REMOVED AS A SINGLE UNIT. AN UNSPECIFIED GUIDE WIRE AND NEW BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466891 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF THE HI-TORQUE VERSACORE GUIDE WIRE, THE COIL SEPARATED FROM THE WHITE PART OF THE GUIDE WIRE, THE COILS DID NOT UNRAVEL. IT WAS STATED THAT GUIDE WIRE DID NOT SEPARATE INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9880126 ↗