HI-TORQUE BALANCE 28000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648013423), received between Mar 22, 2017 and Mar 11, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 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.

• MalfunctionMar 11, 2021Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS WAS GAINED VIA THE GROIN, AND THE 014 HI-TORQUE BALANCE GUIDE WIRE (GW) WAS ADVANCED TOWARDS THE LESION BUT BEFORE IT REACHED THE LAD, IT BECAME CAUGHT ON THE HEAVILY CALCIFIED ANATOMY AND COULD NOT CROSS. DURING REMOVAL OF THE GW, RESISTANCE WAS MET WITH THE ANATOMY AGAIN AND THE COILS BECAME STRETCHED AND UNRAVELED, BUT WAS REMOVED IN ONE PIECE. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11467816 ↗
• MalfunctionOct 2, 2019Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE CIRCUMFLEX CORONARY ARTERY. DURING THE PROCEDURE, THE TIP OF THE HI TORQUE BALANCE GUIDE WIRE BECAME STRETCHED, AND THE SHAPING RIBBON OF THE GUIDE WIRE BECAME UNRAVELED. EVERYTHING ELSE APPEARED TO REMAIN INTACT. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145747 ↗
• InjurySep 10, 2019Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 014 HI-TORQUE BALANCE GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE; HOWEVER, THE TIP UNRAVELED AND SEPARATED. AN UNSPECIFIED STENT WAS USED TO EMBED THE SEPARATED TIP. THE REST OF THE GUIDE WIRE WAS REMOVED WITHOUT ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8984838 ↗
• InjuryMar 22, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY. THE BALANCE GUIDE WIRE WAS ADVANCED WITHOUT ISSUE IN THE ANATOMY, HOWEVER DURING REMOVAL OF THE GUIDE WIRE, THE TIP SEPARATED. THERE WAS NO RESISTANCE DURING REMOVAL. TWO ADDITIONAL UNSPECIFIED GUIDE WIRES WERE USED TO TRAP THE SEPARATED TIP AND RETRIEVE IT FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424347 ↗