HI-TORQUE CONNECT 1012592Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648175022), received between Apr 13, 2020 and Jul 4, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LEFT PULMONARY ARTERY. WHEN ATTEMPTING TO ADVANCE THE CARDIOMEMS DELIVERY SYSTEM OVER THE .018 CONNECT FLEX GUIDE WIRE RESISTANCE WAS FELT AND THE SYSTEM WAS NOT ABLE TO ADVANCE FURTHER. THE WIRE AND DELIVERY SYSTEM WERE REMOVED. THE GUIDE WIRE WAS NOTED TO HAVE COATING SHEARED OFF. A NEW .018 GUIDEWIRE WAS USED ALONG WITH CARDIOMEMS DEVICE AND THE SENSOR WAS DEPLOYED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19674340 ↗
• MalfunctionSep 5, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY POPLITEAL WITH LASER ATHERECTOMY. DURING THE PROCEDURE VIA ANGIOGRAM VISUALIZATION, THE 018 HT CONNECT FLEX GUIDE WIRE POLYMER WAS NOTED TO BE FRAYED. A NEW CONNECT FLEX GUIDE WIRE WAS USED AND THE SAME ISSUE OCCURRED. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. NO COATING WAS LEFT IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681516 ↗
• MalfunctionSep 5, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY POPLITEAL WITH LASER ATHERECTOMY. DURING THE PROCEDURE VIA ANGIOGRAM VISUALIZATION, THE 018 HT CONNECT FLEX GUIDE WIRE POLYMER WAS NOTED TO BE FRAYED. A NEW CONNECT FLEX GUIDE WIRE WAS USED AND THE SAME ISSUE OCCURRED. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. NO COATING WAS LEFT IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681143 ↗
• MalfunctionMar 14, 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 LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS RESTENOSED AND NON CALCIFIED. A CONNECT FLEX WIRE TIP BROKE OFF OFF IN THE RIGHT SFA IN THE NON-ABBOTT STENT OCCLUSION (PREVIOUSLY IMPLANTED IN A SEPARATE PROCEDURE AT AN UNKNOWN DATE). THE PROCEDURE WAS DELAYED FOR AN HOUR AS HE HAD TO USE A SNARE TO RETRIEVE THE BROKEN PIECE. THERE WAS RESISTANCE IN THE LESION WHILE TRYING TO CROSS IT AND COME APART DUE TO RESISTANCE DURING WITHDRAWAL. THE PROCEDURE WAS COMPLETED BY CROSSING WITH A DIFFERENT WIRE WHERE THEY THEN LAYERED THE IN-STENT AREA AND USED A DRUG COATED BALLOON. THE PATIENT WAS SUCCESSFULLY TREATED WITH NO ADVESE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536964 ↗
• MalfunctionSep 7, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POSTERIOR TIBIAL ARTERY. DURING AN ATTEMPT TO RECANALIZE THE POSTERIOR TIBIAL ARTERY, THE TIP OF THE 018 HT CONNECT FLEX GUIDE WIRE (GW) SEPARATED IN THE ANATOMY. THE GUIDE WIRE WAS REMOVED WITH RESISTANCE. A SNARE WAS USED TO REMOVE THE TIP FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. A NON-ABBOTT GUIDE WIRE AND ARMADA BALLOON DILATATION CATHETER (BDC) WERE USED TO SUCCESSFULLY COMPETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368459 ↗
• InjuryMay 21, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. A CONNECT FLEX GUIDE WIRE WAS BEING USED WHEN THE TIP SEPARATED. THE SEPARATED TIP WAS EMBEDDED IN THE VESSEL USING AN UNSPECIFIED STENT. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11866712 ↗
• InjuryApr 13, 2020Entrapment of Device; Material Separation; Material Too Soft/Flexible; Entrapment of Device; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIBIAL LESION. A 0.18 HI-TORQUE CONNECT FLEX PERIPHERAL GUIDE WIRE WAS BEING ADVANCED WHEN IT PROLAPSED INSIDE THE ANATOMY AT THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE, BUT THE TIP BECAME STUCK IN A COLLATERAL VESSEL. RESISTANCE WAS NOTED AND THE TIP OF THE GUIDE WIRE BROKE OFF AND REMAINS IN THE SMALL COLLATERAL VESSEL IN THE PATIENT. THE PROXIMAL END OF THE GUIDE WIRE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMMAND 14 GUIDEWIRE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9955724 ↗