Hi-Torque Proceed™ 1030902Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648321429), received between Nov 3, 2020 and Oct 12, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 170T HT PROCEED GUIDE WIRE WAS ATTEMPTED TO ADVANCE; HOWEVER, THE TIP BECAME STUCK WITH ANATOMY. WHEN ATTEMPTING TO PULL BACK THE GUIDE WIRE IT UNRAVELED. THE GUIDE WIRE REMAINED IN ONE PIECE AND WAS REMOVED SUCCESSFULLY. AS SEVERAL UNSPECIFIED GUIDE WIRES WERE ATTEMPTED TO CROSS BEFORE THE USE OF THE PROCEED GUIDE WIRE THE PHYSICIAN DECIDED TO ABANDON THE CASE. 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 12616085 ↗
• MalfunctionJul 16, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN HEAVILY CALCIFIED PERONEAL ARTERY. THE HT PROCEED GUIDE WIRE WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE CALCIFICATION IN THE TARGET VESSEL. THE GUIDE WIRE WAS UNABLE TO ADVANCE TO THE TARGET LESION. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE; HOWEVER, IT COULD NOT BE PULLED INTO THE GUIDE CATHETER. THE .014 GUIDE CATHETER WAS EXCHANGED FOR A .035 GUIDE CATHETER. THE GUIDE WIRE WAS THEN ABLE TO BE REMOVED. IT WAS NOTED THAT A LARGE PIECE OF CALCIFICATION WAS CAUGHT ON THE GUIDE WIRE COILS AND IT WAS ASSUMED THAT THIS WAS CAUSING THE DIFFICULT REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12184387 ↗
• MalfunctionJun 3, 2021Break; Failure to Advance; Difficult to Advance; Break; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS POSTERIOR TIBIAL ARTERY. A 170T 3CM ANGLED HT PROCEED GUIDE WIRE (GW) WAS ADVANCED INTO THE ANATOMY BUT MET RESISTANCE WITH THE 014 NON-ABBOTT CROSSING SUPPORT CATHETER. DUE TO THE RESISTANCE, THE WIRE WAS PULLED BACK AND REMOVED. IT WAS NOTED THAT ABOUT 3CM OF THE PROXIMAL TIP OF THE WIRE WAS BROKEN BUT NOT COMPLETELY SEPARATED. AN 014 COMMAND WIRE WAS THEN USED TO SUCCESSFULLY 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 11936270 ↗
• InjuryApr 2, 2021Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 100% STENOSED POSTERIOR TIBIAL ARTERY, BELOW THE KNEE. A 300CM HT COMMAND ES GUIDE WIRE (GW) WAS ADVANCED TO THE LESION BUT COULD NOT CROSS THE HEAVY CALCIFICATION AND WAS REMOVED WITHOUT ISSUE. AN HT PROCEED ANGLED GUIDE WIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE WIRE WAS PULLED BACK TO REPOSITION, AND RESISTANCE WAS NOTED. DURING REMOVAL, THE WIRE SEPARATED IN THE ANATOMY. THE COILS WERE SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED PORTIONS, BUT THE PLATINUM TIP COULD NOT BE REMOVED AND REMAINS IN THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11609051 ↗
• MalfunctionNov 3, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT AN OCCLUDED TIBIAL PERONEAL TRUNK ARTERY, BELOW THE KNEE WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY THAT WAS 100% STENOSED. A HI-TORQUE PROCEED GUIDE WIRE (GW) COULD NOT CROSS THE TARGET LESION DUE TO THE HEAVY CALCIFICATION AND RESISTANCE WITH THE ANATOMY WAS NOTED DURING REMOVAL. THEN TWO FIELDER ASAHI GUIDEWIRES WERE USED. HOWEVER, THESE GUIDE WIRES COULD NOT CROSS THE TARGET LESION ALSO DUE TO THE ANATOMICAL CHALLENGES. THEREFORE, THE PHYSICIAN RE-SHAPED THE HI-TORQUE PROCEED GUIDE WIRE, AND USED A SECONDARY BEND. THE GW WAS RE-INSERTED BUT STILL COULD NOT CROSS THE TARGET LESION DUE TO THE ANATOMY. THE GW WAS REMOVED WITHOUT ISSUE. ANOTHER HI-TORQUE PROCEED GUIDE WIRE WAS USED, AND THIS GW WAS SUCCESSFULLY ADVANCED. THE TARGET LESION WAS TREATED AND THE PATIENT IS STABLE. NO OTHER ISSUES NOTED. 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 10780276 ↗