HI-TORQUE WINN 1012467Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648156823), received between Feb 14, 2017 and Feb 20, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2018Detachment Of Device Component; Improper or Incorrect Procedure or Method; Failure to Advance; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO, CHRONIC TOTAL OCCLUSION OF THE ANTERIOR TIBIAL ARTERY. A 300 CM WINN GUIDE WIRE WAS USED; HOWEVER, THE TIP OF THE GUIDE WIRE PROLAPSED DUE TO THE ANATOMY WHEN THE GUIDE WIRE WAS BEING TORQUED. THEN THE GUIDE WIRE BECAME STUCK DURING ADVANCEMENT DUE TO THE ANATOMY, CAUSING THE TIP TO BECOME SEPARATED. THE TIP WAS EMBEDDED IN HEALTHY TISSUE AND THERE WAS A FAILED ATTEMPT TO SNARE IT. THE PATIENT WAS IN STABLE CONDITION AND THE BLOOD FLOW IN THE LEG WAS NOT AFFECTED BY THE EMBEDDED TIP OF THE GUIDE WIRE. THEREFORE, THE SEPARATED GUIDE WIRE TIP WAS LEFT IN THE ANATOMY, AND THE DEVICE WAS REMOVED INDEPENDENTLY THROUGH AN UNSPECIFIED INTRODUCER SHEATH TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7284307 ↗
• InjuryFeb 14, 2017Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A HT WINN GUIDE WIRE WAS ADVANCED RETROGRADE THROUGH THE ANTERIOR TIBIALIS; HOWEVER, THE GUIDE WIRE COULD NOT CROSS AND THE TIP BECAME SEPARATED DUE TO THE HEAVY CALCIFICATION. THE TIP WAS NOT RETRIEVED. IT WAS STATED THAT THE PHYSICIAN FELT COMFORTABLE LEAVING THE TIP IN AS IT WAS IN A SUBINTIMAL PLANE OF THE VESSEL IN THE SFA AND THERE WAS NO BLOOD FLOW REACHING THE SEGMENT TO INJURE THE PATIENT. ADDITIONALLY, THE PROCEDURE WAS UNSUCCESSFUL AND THE PATIENT WILL BE COUNSELED ON HAVING BYPASS SURGERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6329964 ↗