HI-TORQUE WINNRecalls & reported problems across all models

We found 4 models of HI-TORQUE WINN by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2017 and Sep 9, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HI-TORQUE WINN problems

HI-TORQUE WINN models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HI-TORQUE WINN 1012475

  WIRE, GUIDE, CATHETER
  14 reports
• HI-TORQUE WINN 1012469

  WIRE, GUIDE, CATHETER
  4 reports
• HI-TORQUE WINN 1012467

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE WINN 1012474

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE WINN adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 28, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502555 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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