HI-TORQUE VERSACORE 1012068-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648124211), received between Mar 30, 2018 and May 29, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 18, 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.

• MalfunctionMay 29, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT MADE BY THE PHYSICIAN THAT DURING PREVIOUS USE OF THE HT VERSACORE MODIFIED J 300 CM GUIDE WIRES, UNSPECIFIED STENTS AND BALLOONS HAVE HAD DIFFICULTY ADVANCING OVER THE WIRE AS WELL AS DIFFICULTY BEING REMOVED FROM THE WIRE. THEY SEEM TO BE STICKING TO THE GUIDE WIRE. THERE WERE NO ISSUES WITH ADVANCEMENT OR REMOVAL OF THE GUIDE WIRE ITSELF. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8652471 ↗
• InjuryJul 3, 2018Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY THAT DID NOT HAVE ANY TORTUOSITY. THE RIGHT ANTERIOR TIBIAL ARTERY WAS ACCESSED WITH A 6 FR SHEATH. A 300 CM VERSACORE GUIDE WIRE WAS THEN ADVANCED TOWARDS THE LESION. AN ATTEMPT WAS THEN MADE TO ADVANCE THE GUIDE WIRE THROUGH THE LEFT GROIN ACCESS USING A SNARE. THE GUIDE WIRE WAS SNARED IN THE AORTA TO PROVIDE STRONG SUPPORT TO THEN ADVANCE THE SHEATH OVER THE GUIDE WIRE FROM THE LEFT GROIN ACCESS TO THE RIGHT SUPERFICIAL FEMORAL ARTERY. HOWEVER, AS THE TIP OF THE GUIDE WIRE WAS SNARED AND WAS PULLED INTO THE LEFT ILIAC ARTERY, THE TIP BEGAN TO UNRAVEL. THE DEVICE DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. THE CORE REMAINED INTACT AND THERE WAS DIFFICULTY IN REMOVING THE DEVICE. THEREFORE, THE PHYSICIAN CUT THE TIP AND ADVANCED A GUIDING CATHETER OVER THE GUIDE WIRE TO REMOVE BOTH PARTS FROM THE ANATOMY. THE PROCEDURE WAS THEN ABORTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661009 ↗
• MalfunctionMar 30, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO THE MODERATE TO HEAVILY TORTUOUS, 100% STENOSED, PROXIMAL TO DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). AFTER PLACEMENT OF A HI-TORQUE (HT) VERSACORE GUIDE WIRE, A 4 X 150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED, BUT MET RESISTANCE WITH THE GUIDE WIRE AND WAS ONLY ABLE TO REACH THE PROXIMAL RSFA. THE BALLOON OF THE PTA CATHETER WAS INFLATED AND DEFLATED WITH NO ISSUES NOTED. DURING REMOVAL OF THE PTA CATHETER FROM THE ANATOMY, IT AGAIN MET RESISTANCE AND BECAME STUCK ON THE GUIDE WIRE. A NON-ABBOTT GUIDE WIRE WAS PLACED TO SERVE AS A BUDDY WIRE SO ACCESS WAS NOT LOST AND THE HT VERSACORE GUIDE WIRE & ARMADA PTA CATHETER WERE REMOVED FROM THE ANATOMY AS A UNIT. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL STENTING OF THE COMPLETE RSFA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386990 ↗