Hi-Torque Proceed™ 1030904Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648321382), received between Dec 1, 2020 and Jun 10, 2025 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN AN UNSPECIFIED ARTERY WITH HEAVY CALCIFICATION. THE HI-TORQUE (HT) PROCEED GUIDE WIRE WAS ADVANCED WITHOUT ISSUE; HOWEVER, THE TIP UNRAVELED. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179127 ↗
• InjuryAug 30, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL VESSEL OF THE LEFT LEG WITH 90% STENOSIS, HEAVY CALCIFICATION AND NO TORTUOSITY. THE HI-TORQUE (HT) PROCEED GUIDE WIRE WAS ADVANCED WITH THE SUPPORT CATHETER AND HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT WHEN THE TIP SEPARATED IN THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL, HOWEVER, THERE WAS NO FORCE APPLIED. THE TIP WAS NOTED TO BE STUCK IN THE VESSEL WALL AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT IN RETRIEVAL AS THE VESSEL WAS TOO SMALL TO ADVANCE A DEVICE. THE PATIENT IS RETURNING FOR A BY-PASS PLANNED EARLIER ON AND NOT DUE TO THE SEPARATED PORTION IN THE ANATOMY. HOWEVER, THE SEPARATED TIP WILL BE ATTEMPTED TO BE REMOVED DURING THE BY-PASS SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17650646 ↗
• InjuryAug 21, 2023Break; Difficult to Remove; Material Separation; Stretched; Failure to Advance; Break; Difficult to Remove; Material Separation; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TIBIAL ARTERY. THE HT PROCEED GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED; HOWEVER, IT WAS HEAVILY CALCIFIED THAT THE GUIDE WIRE BECAME STUCK. WHEN ATTEMPTING TO REMOVE RESISTANCE WAS FELT WITH ANATOMY AND TIP BEGAN TO STRETCH, UNRAVEL AND THEN SEPARATE INTO PIECES. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTIONS AND NO SEPARATED PIECES OF THE GUIDE WIRE REMAINED IN THE PATIENT. IT IS UNCLEAR EXACTLY WHERE THE SEPARATION OCCURRED ON THE DEVICE AS IT SEPARATED INTO MULTIPLE PIECES. ALSO, IT WAS NOTED MULTIPLE UNSPECIFIED DEVICES WERE USED TO ATTEMPT TO REMOVE THE GUIDE WIRE IN ONE PIECE, BUT NOT UNTIL THE SNARE DEVICE WAS USED WAS IT ABLE TO BE REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17589597 ↗
• InjuryJul 14, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT TIBIAL PERONEAL TRUNK WITH 100% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE HI-TORQUE (HT) PROCEED GUIDE WIRE FAILED TO CROSS DUE TO THE ANATOMY AND ABOUT 1CM OF THE TIP SEPARATED INSIDE THE PATIENT. THERE WAS NO RESISTANCE DURING REMOVAL. THERE WAS NO ATTEMPT TO RETRIEVE THE SEPARATED PORTION AND A STENT WAS LATER IMPLANTED TO CRUSH THE SEPARATED TIP IN THE VESSEL. ANOTHER HT COMMAND 14 ES GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17326122 ↗
• MalfunctionOct 1, 2022Break; Stretched; Failure to Advance; Material Deformation; Break; Stretched; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY TOTAL OCCLUDED MID SUPERFICIAL FEMORAL ARTERY. A HI-TORQUE PROCEED WAS BEING ADVANCED WHEN IT WAS NOTED THAT THERE WAS A LONGER SPACE (DEDUCED TO BE STRETCHED) BETWEEN THE CORE AND TIP (GUIDE WIRE STILL REMAINING IN ONE PIECE). THERE WAS SOME RESISTANCE NOTED DUE TO ANATOMY. HOWEVER, WHILE ATTEMPTING TO ADVANCE, THE CORE COILING WOULD LOOK COMPRESSED. IT WAS DECIDED TO REMOVE THE GUIDE WIRE. PER THE PHYSICIAN, THE GUIDE WIRE REMAINED IN ONE PIECE AND THERE WAS NO SEPARATION NOTED. ADDITIONALLY, IT WAS CONFIRMED NOT TO BE UNRAVELED. ANOTHER PROCEED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS NOTED: [A PORTION OF THE TIP COILS STRETCHED, UNRAVELED AND SEPARATED AT THE NOTED BENT CORE. THE CORE WAS STILL INTACT.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523295 ↗
• MalfunctionAug 22, 2022Break; Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Break; Difficult to Remove; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS POPLITEAL ARTERY THAT WAS 80% STENOSED. DURING ADVANCEMENT IT WAS NOTED THAT THE HYDROPHILIC COATING OF A HI-TORQUE PROCEED GUIDE WIRE (GW) HAS HIGH FRICTION, AND THE TIP OF THE GW BECAME STUCK IN THE CALCIFIED LESION. AFTER PULL BACK OF THE GW, THE COILS OF THE GW TIP WAS UNCOILING, STRETCHED AND KINKED. ANOTHER GW WAS 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 15272283 ↗
• InjuryNov 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE 0.14 HI-TORQUE PROCEED GUIDE WIRE SEPARATED IN THE ANATOMY. THE SEPARATED PORTION WAS RETRIEVED VIA SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882782 ↗
• InjuryJun 3, 2021Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY. A PROCEED GUIDE WIRE WAS ATTEMPTED TO CROSS THROUGH THE COMPLICATED LESIONS BUT MET RESISTANCE WITH THE ANATOMY AND WHEN PULLING BACK TO ADJUST THE DISTAL TIP BROKE OFF. THE TIP REMAINS IN THE SUBINTIMAL SPACE OF THE VESSEL AS IT REACHED THE LESION. PHYSICIAN IS NOT CONCERNED AS IT REMAINS IN THE SUBINTIMAL SPACE WHERE IT'S NOT FLOW LIMITING. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11932693 ↗
• MalfunctionMay 27, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, TORUOUD LESION IN THE ANTERIOR TIBIAL ARTERY. DURING USE OF THE PROCEED GUIDE WIRE, THE WIRE UNRAVELED AND THE CORE BROKE BUT WAS HELD TOGETHER BY THE COILS. THE ENTIRE WIRE WAS ABLE TO BE PULLED SLOWLY OUT OF THE PATIENT AND NO PORTION OF THE GUIDE WIRE WAS LEFT IN THE PATIENT. A NEW NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895857 ↗
• MalfunctionApr 28, 2021Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 90% STENOSED LESION IN THE LEFT POPLITEAL ARTERY. A 3CM HT PROCEED 220T ANGLED GUIDE WIRE (GW) WAS SLOWLY ADVANCED TOWARDS THE LESION BUT COULD NOT CROSS THE NON-ABBOTT SUPPORT CATHETER. DURING REMOVAL, IT CAUGHT ON CALCIUM AND THE COILS STRETCHED. THEY CONCLUDED THE PROCEDURE AT THAT POINT. NO OTHER DEVICE CROSSED THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11742453 ↗
• InjuryMar 29, 2021Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY TORTUOUS, HEAVILY CALCIFIED OSTIUM OF THE SUPERIOR MESENTERIC ARTERY. A HI-TORQUE (HT) PROCEED GUIDE WIRE WAS ADVANCED TO THE LESION, BUT WITH MUCH RESISTANCE FROM THE ANATOMY. SLIGHT FORCE WAS APPLIED AND THE GUIDE WIRE WAS ULTIMATELY ADVANCED AGAINST RESISTANCE TO THE LESION. ONCE AT THE LESION IT WAS NOTED THAT THE TIP HAD SUBSEQUENTLY SEPARATED (STILL REMAINING AT THE LESION). PHYSICIAN DECIDED TO END THE CASE AND CONTINUE ON ANOTHER UNSPECIFIED DATE. IT WAS CONFIRMED THAT THE TIP WILL NOT BE RETRIEVED AS IT WAS DEEMED INSIGNIFICANT TO THE PATIENT'S HEALTH AND REMAINS IN THE TIGHT LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11581552 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER EXTREMITY. THE HT PROCEED GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE NOTED HOWEVER WHEN TORQUING THE DEVICE, THE CORE SEPARATED. THE TIP COILS WERE STILL INTACT THEREFORE THE GUIDE WIRE WAS SIMPLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10987026 ↗
• MalfunctionDec 9, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED DE NOVO LEFT PERONEAL ARTERY. A HT PROCEED GUIDE WIRE WAS ABLE TO SUCCESSFULLY CROSS THE LESION. THEN A 1X10MM NON-ABBOTT BALLOON WAS DELIVERED OVER THE WIRE. THE BALLOON RUPTURED DURING DEPLOYMENT AT 14 ATMOSPHERES. WHEN PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON IT FELT STUCK. PHYSICIAN TRIED TO MOVE THE HT PROCEED AND IT FELT STUCK TOO. THE GUIDE WIRE WAS EVENTUALLY FREED AND REMOVED AGAINST RESISTANCE AND WITH SLIGHT FORCE. A PIECE OF DEBRIS WAS ON THE DISTAL TIP OF THE WIRE UPON REMOVAL WHICH WAS CONFIRMED TO BE DEBRIS OF THE VESSEL WALL. PER THE PHYSICIAN, IT IS UNKNOWN WHAT THE GUIDE WIRE MET RESISTANCE WITH DURING REMOVAL. 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 10977775 ↗
• InjuryDec 1, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION THROUGH AN ANKLE STICK INTO THE POSTERIOR TIBIAL ARTERY, INTO AN OCCLUDED FEMORAL TO POPLITEAL BYPASS INTO THE UPPER THIGH REGION. THE HT PROCEED 220T GUIDE WIRE WAS ADVANCED WITH A SUPPORT CATHETER WHILE BEING CONNECTED TO A GUIDE WIRE CONTROLLER; HOWEVER, RESISTANCE WITH THE COMPLETELY OCCLUDED LESION WAS FELT AND THE TIP BROKE. THE TIP WAS IN AN ACUTE BEND WHEN THE GUIDE WIRE CONTROLLER WAS BEING ACTUATED. THE WIRE WAS PULLED LEAVING THE TIP WITHIN THE OCCLUDED BYPASS SEGMENT. STILL FLUORO IMAGES SHOWED THE TIP AT THE TOP OF THE BYPASS GRAFT WITH THE COIL WIRE TERMINATING AT THE BOTTOM OF THE BYPASS NEAR THE KNEE. AS THE BYPASS COULD NOT BE REVASCULARIZED AND THE REMNANT OF WIRE WAS COMPLETELY CONTAINED WITHIN THE OCCLUDED GRAFT AND WAS NOT FREE FLOATING THERE WAS NO ATTEMPT TO RETRIEVE IT. A NON-ABBOTT WIRE WAS ADVANCED USING THE GUIDE WIRE CONTROLLER AND MADE IT TO THE PROXIMAL END OF THE BYPASS JUNCTION BUT NO PATH TO THE NATIVE VESSEL WAS IDENTIFIED AND THE BYPASS WAS LEFT UNTREATED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. USER FACILITY MEDWATCH RECEIVED STATES: ¿DURING AORTAGRAM AND RUN O

  Patient problems: Foreign Body In Patient

  MAUDE report 10928583 ↗