HI-TORQUE ALL STAR 1001741Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648013829), received between May 24, 2017 and Dec 23, 2019 — classified as 3 injuries.

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 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.

• InjuryDec 23, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE. THE STENT DELIVERY SYSTEM WAS ADVANCED OVER AN ALLSTAR GUIDE WIRE AND THE STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING STENT DEPLOYMENT, THE STENT JAILED THE DIAGONAL ARTERY. THE ALLSTAR GUIDE WIRE WAS REMOVED FROM THE LAD AND REDIRECTED INTO THE DIAGONAL ARTERY. AN ATTEMPT WAS MADE TO ADVANCE AN UNSPECIFIED DILATATION CATHETER OVER THE GUIDE WIRE; HOWEVER, THE DILATATION CATHETER WAS UNABLE TO BE ADVANCED TO THE TARGET SITE. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE; HOWEVER, IT WAS CAUGHT ON THE STENT AND SEPARATED IN THE PATIENT ANATOMY. THERE WAS NO ATTEMPT TO REMOVE THE SEPARATED GUIDE WIRE SEGMENT AND BALLOON INFLATION WAS PERFORMED TO ADHERE THE GUIDE WIRE TO THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9512880 ↗
• InjuryJul 25, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX AND OBTUSE MARGINAL CORONARY ARTERY. AT THE CONCLUSION OF THE PROCEDURE, WHEN ALL STENTING WAS COMPLETED AS A 014 ALLSTAR GUIDE WIRE (GW) WAS BEING REMOVED, RESISTANCE WAS FELT WITH THE ANATOMY AND THE GW SEPARATED INTO TWO PIECES. THE DISTAL PORTION OF THE GUIDE WIRE STILL REMAINS IN THE ANATOMY. THE PATIENT IS FINE. THERE WAS NO RESISTANCE NOTED WHILE ADVANCING. IT IS UNKNOWN IF THE SEPARATED PORTION OF THE GUIDE WIRE WILL BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7720721 ↗
• InjuryMay 24, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). AN ALLSTAR GUIDE WIRE WAS ADVANCED DOWN THE RCA INTO THE POSTERIOR LATERAL ARTERY (PLA) AND A WHISPER GUIDE WIRE INTO THE POSTERIOR DESCENDING CORONARY ARTERY. AN UNKNOWN STENT DELIVERY SYSTEM WAS ADVANCED DOWN ON THE WHISPER GUIDE WIRE AND THE STENT WAS DEPLOYED AT 16 ATMOSPHERES WITH THE ALLSTAR GUIDE WIRE BEHIND THE STENT TO PROTECT THE PLA. BOTH GUIDE WIRES WERE PULLED BACK AND IT WAS NOTICED THAT ONE OF THE WIRES BROKE (SEPARATED). THE PHYSICIAN WAS UNABLE TO DETERMINE WHICH WIRE SEPARATED; HOWEVER, A PIECE OF THE WIRE WAS LEFT INSIDE THE PATIENT ANATOMY. THE PATIENT HAD OTHER ISSUES WITH CORONARY ARTERY DISEASE AND THE PHYSICIAN DIDN'T WANT TO LEAVE THE WIRE INSIDE THE PATIENT SO THE PATIENT WAS SENT TO SURGERY. THE SURGEON WAS ABLE TO REMOVE THE WIRE PIECE FROM BEHIND THE STENT AND THE PATIENT WENT HOME FEELING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6589748 ↗