HI-TORQUE WINN 1012475Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648156908), received between Aug 14, 2017 and Sep 9, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Difficult to Remove; Material Separation

  It was reported that the procedure was to treat a lesion in the superficial femoral artery (SFA) with 99% stenosis, heavy calcification and mild tortuosity. The Hi-Torque Winn 200 guidewire was used in the procedure. Upon removal, resistance was noted due to the heavy calcification and no guide catheter used and the distal tip detached. The detached distal segment remained within the calcified occlusion without any attempts at retrieval. The procedure was stopped and recanalization was not achieved. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50697790 ↗
• MalfunctionApr 29, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE WINN GUIDE WIRE WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE ANATOMY AND THE TEFLON COATING WAS STRIPPED FROM THE CORE. AFTER THE PROCEDURE IT WAS NOTED, THERE WERE PARTICLES OF THE GUIDE WIRE IN THE 3.0X120MM ARMADA 18 BALLOON DILATATION CATHETER. NO PORTION OF THE TEFLON COATING WAS LEFT IN THE PATIENT ANATOMY. 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 21928761 ↗
• InjuryDec 18, 2024Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC, TOTALLY OCCLUDED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HI TORQUE WINN GUIDE WIRE WAS BEING ADVANCED AND THERE WAS RESISTANCE WITH THE ANATOMY, WHEN THE TIP OF THE DEVICE SHEARED OFF INTO A CHUNK OF CALCIFICATION. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE ANATOMY AND THE WINDSHIELD WIPER METHOD WAS USED TO REMOVE THE WIRE FROM THE CALCIUM. NO ATTEMPTS WERE MADE TO RETRIEVE THE TIP, IT REMAINS LODGED IN THE CALCIUM. THE PATIENT HAS BEEN REFERRED TO A DIFFERENT PHYSICIAN FOR FOLLOW UP. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20964725 ↗
• InjuryJul 24, 2024Material Separation; Failure to Advance; Difficult to Advance; Material Separation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED PROXIMAL POPLITEAL ARTERY. AN ATTEMPT TO ADVANCE THE .014 HI-TORQUE WINN GUIDE WIRE WAS MADE; HOWEVER, MET RESISTANCE WITH ANATOMY CAUSING THE TIP BECAME STUCK IN THE PATIENT'S ANATOMY AND SEPARATE. THE TIP REMAINED LODGED IN THE ANATOMY AND NO INTERVENTION WAS MADE TO REMOVE THE TIP. THE REST OF THE GUIDE WIRE WAS SIMPLY WITHDRAWN WITH NO RESISTANCE FELT DURING REMOVAL. A NEW DEVICE WAS USED TO CONTINUE AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19818894 ↗
• MalfunctionMar 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN REMOVING THE HT WINN GUIDE WIRE FROM ITS PACKAGING IT WAS OBSERVED THAT THE DISTAL PART OF THE GUIDE WIRE TIP HAD NO COATING AND THE COILS WERE EXPOSED. ANOTHER GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18880248 ↗
• MalfunctionFeb 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN REMOVING THE HT WINN GUIDE WIRE FROM ITS PACKAGING IT WAS OBSERVED THAT HE DISTAL PART OF THE GUIDE WIRE TIP COATING HAD PEELED AND THE COILS WERE EXPOSED. ANOTHER GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743769 ↗
• InjuryDec 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RESTENOSED AND CHRONIC TOTALLY OCCLUDED LESION IN THE ILIAC VEIN. A 014 HT WINN 200T GUIDE WIRE WAS ADVANCED FROM RIGHT TO LEFT PASSING AN OCCLUDED STENT. THE GUIDE WIRE WAS SUPPORTED WITH AN UNSPECIFIED CATHETER AND AN UNSPECIFIED SUPPORT CATHETER. THERE WAS 1CM LEFT TO PASS THE OCCLUDED STENT; HOWEVER, IT WAS DECIDED TO CHANGE THE CATHETER. THE CATHETER AND SUPPORT CATHETER WERE REMOVED. IT WAS THEN NOTED THAT THE GUIDE WIRE HAD SEPARATED INTO TWO PIECES. THE PROXIMAL PORTION OF THE GUIDE WIRE WAS REMOVED, BUT 20CM OF THE DISTAL GUIDE WIRE REMAINED IN THE PATIENT. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE SEPARATED PIECE. THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW PUNCTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11006302 ↗
• InjuryNov 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY TOTAL OCCLUDED (CTO), HEAVILY CALCIFIED DE NOVO LESION IN THE ANTERIOR TIBIAL ARTERY. A 014 HT WINN GUIDE WIRE WAS ADVANCED HOWEVER THE TIP OF THE GUIDE WIRE SEPARATED. NO ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION AND THE TIP REMAINS INSIDE THE VESSEL. THE PROCEDURE WAS DISCONTINUED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10887973 ↗
• InjuryAug 18, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED DE NOVO SUPERFICIAL FEMORAL ARTERY THAT WAS 100% STENOSED. A HI-TORQUE WINN 200T GUIDE WIRE WAS ADVANCED SUBINTIMAL WITH RESISTANCE DUE TO ANATOMY AND WHEN PULLED BACK, THE WIRE TIP BROKE OFF AND WAS LEFT IN THE PATIENT. AFTER BALLOONING THE ARTERY, THE SEPARATED TIP WAS JAILED IN WITH A SUPERA STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10420569 ↗
• InjuryMar 25, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY. A WINN 200T 300CM GUIDE WIRE WAS ADVANCED WHEN IT FELT RESISTANCE WITH THE ANATOMY. THE GUIDE WIRE TIP COILS SEPARATED AND REMAINS IN THE PATIENT ANATOMY; THERE WAS NO INTERVENTION PERFORMED, NOR IS ANY INTERVENTION PLANNED. THERE WAS NO RESISTANCE DURING WITHDRAWAL, AND A NEW GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT IS DOING FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9877945 ↗
• MalfunctionDec 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A HI-TORQUE WINN 200T 300CM GUIDE WIRE WAS USED ON (B)(6) 2019, AND AFTER THE PROCEDURE, IT WAS NOTED THAT THE EXPIRATION DATE WAS 05/31/2019. 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 9458892 ↗
• InjuryAug 27, 2019Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND CHRONIC TOTALLY OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY. RESISTANCE WITH THE ANATOMY WAS FELT WHEN ADVANCING THE 014 HT WINN GUIDE WIRE, FORCE WAS APPLIED TO TRY AND GET IT THROUGH; HOWEVER, THE TIP SEPARATED. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE SEPARATED TIP. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936711 ↗
• MalfunctionApr 13, 2018Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION DE NOVO LESION IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED, 80% STENOSED, DISTAL, SUPERFICIAL FEMORAL ARTERY (SFA) USING 014 HI-TORQUE WINN GUIDE WIRE. REPORTEDLY, THE WINN GUIDE WIRE WAS ADVANCED, BUT MET RESISTANCE AND THE TIP BROKE, BUT REMAINED IN ONE PIECE. THE WINN GUIDE WIRE WAS REMOVED FROM THE ANATOMY AND THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AT THAT POINT AND TREAT THE PATIENT WITH ANTICOAGULANT MEDICATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429149 ↗
• InjuryAug 14, 2017Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE POSTERIOR TIBIAL ARTERY. RESISTANCE WITH THE ANATOMY WAS FELT WHILE ADVANCING A .014 HT WINN GUIDE WIRE. THE GUIDE WIRE SEPARATED AND THE TIP REMAINED IN THE OCCLUDED PORTION OF THE ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN STENT. THE PATIENT IS DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6792845 ↗