HI-TORQUE ALL STAR 1001740Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648013812), received between Mar 10, 2017 and Aug 14, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE WHEN ATTEMPTING TO SHAPE THE .014 ALLSTAR GUIDE WIRE TIP WITH THE UNSPECIFIED GUIDE WIRE INTRODUCER, THE GUIDE WIRE SPLIT INTO TWO AT THE END. A NEW ALLSTAR GUIDE WIRE WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808874 ↗
• InjuryJun 11, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LESION IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY, THAT WAS 90% STENOSED. AN UNSPECIFIED STENT WAS DEPLOYED AND THE STENT WAS POST DILATED. UPON REMOVAL OF THE 014" ALLSTAR GUIDE WIRE, IT WAS NOTED THAT THE GUIDE WIRE WAS PINNED AGAINST THE METAL STENT STRUT AND VESSEL WALL AND RESISTANCE WAS NOTED. THE GUIDE WIRE WAS PULLED AGAINST RESISTANCE AND THE TIP OF THE GUIDE WIRE SEVERED OFF. THE TIP REMAINED PINNED BETWEEN THE METAL STENT AND THE VESSEL WALL. NO ADDITIONAL GUIDE WIRE WAS NEEDED AS THE PROCEDURE WAS COMPLETED. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22186059 ↗
• InjuryMay 22, 2023Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3CM, 014 ALLSTAR GUIDE WIRE (GW) WAS BEING REMOVED FROM THE ANATOMY, WHEN RESISTANCE WAS MET WITH AN IMPLANTED STENT, AND THE GUIDE WIRE BECAME JAILED. THE JAILED PORTION OF THE GUIDE WIRE SEPARATED FROM THE REMAINDER OF THE WIRE, AND REMAINS JAILED WITHIN THE IMPLANTED STENT, IN THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16975196 ↗
• InjuryMar 10, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI), THE TIP OF THE ALLSTAR WIRE BROKE OFF IN THE PATIENT. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED SEGMENT BUT WAS NOT UNSUCCESSFUL. THE PATIENT NEEDED TO BE TRANSFERRED TO ANOTHER HOSPITAL FOR BYPASS SURGERY. THE TIP WAS LEFT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 6396669 ↗