HI-TORQUE WINN 1012469Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648156847), received between Dec 13, 2021 and Aug 6, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT RESISTANCE WAS MET WITH THE WINN GUIDEWIRE AND THE CHALLENGING ANATOMY. APPROXIMATELY 3 MM OF THE GUIDEWIRE TIP BROKE DURING ADVANCEMENT WITH RESISTANCE TO THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 100% STENOSIS LESION AND CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE SEPARATED TIP REMAINS LODGED IN THE CTO LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE. AN HT COMMAND ES GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19923652 ↗
• MalfunctionAug 3, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PERONEAL ARTERY. THE 014 HT WINN 80 GUIDE WIRE WAS USED SEVERAL TIMES AND IT WAS FELT THAT THE HYDROPHILIC COATING WAS COMING OFF THE DEVICE. THERE WAS NO RESISTANCE REPORTED DURING THE PROCEDURE. UPON REMOVAL, THE TIP OF THE WIRE SHOWED EXPOSED MATERIAL WITHOUT HYDROPHILIC COATING. ANOTHER COMMAND ES GUIDE WIRE WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17451384 ↗
• InjuryMar 16, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 014 WINN 80 300CM GUIDEWIRE (GW) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, WHEN TORQUEING THE GW 10MM OF THE TIP SNAPPED OFF IN THE OCCLUDED VESSEL AND THE TIP OF THE GW BECAME EMBEDDED IN THE VESSEL. DUE TO THE VESSEL BEING TOTALLY OCCLUDED THERE WAS NO ATTEMPT TO RETRIEVE THE SEPARATED GW TIP; THEREFORE, THE TIP OF THE GW REMAINED EMBEDDED IN THE VESSEL AND NO FURTHER TREATMENT WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16553839 ↗
• MalfunctionDec 13, 2021Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. WHILE TRYING TO REMOVE THE DEVICE FROM THE ANATOMY, RESISTANCE WAS FELT WITH THE MICROCATHETER AND THE COATING ON THE WINN GUIDE WIRE STRIPPED OFF INSIDE OF THE MICROCATHETER. THE GUIDE WIRE AND THE MICROCATHETER HAD TO BE REMOVED AS A SINGLE UNIT. NO COATING STRIPPED OFF IN THE ANATOMY, AS IT REMAINED INSIDE OF THE MICROCATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12985034 ↗