HI-TORQUE INFILTRAC 1030003JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648233715), received between Oct 21, 2020 and Sep 23, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS, MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE HI-TORQUE (HT) INFILTRAC GUIDE WIRE CROSSED THE LESION, HOWEVER, THE GUIDE WIRE HAD EXPOSED A THIN WIRE LIKE PIECE IN THE PROXIMAL END AND UNRAVELED. THE GUIDE WIRE STARTED TO COIL AROUND THE PROXIMAL END NOT ALLOWING ANY DEVICE TO CROSS OVER IT. THE CORE OF THE GUIDE WIRE IS IN ONE PIECE, HOWEVER, IT IS UNKNOWN IF THE COILS DETACHED FROM THE CORE OF THE GUIDE WIRE. A GUIDE LINER WAS NOT USED. ANOTHER 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 15473187 ↗
• MalfunctionDec 1, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY TORTUOUS RIGHT CORONARY ARTERY. AN INFILTRAC 3/190CM GUIDE WIRE WAS INSERTED INTO THE ANATOMY. IT WAS NOTED THAT RESISTANCE WAS FELT AS IT WAS AN IN-STENT RESTENOSIS OCCLUSION. DURING ADVANCEMENT, THE GUIDE WIRE TIP SEPARATION INTO TWO PIECES. ALTHOUGH THE TIP SEPARATED, THE ENTIRE GUIDE WIRE WAS ABLE TO BE REMOVED WITHOUT PERFORMING INTERVENTION. 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 12908859 ↗
• InjuryNov 2, 2021Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT AN INFILTRAC PLUS GUIDE WIRE FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND REMOVAL. THE GUIDE WIRE TIP SEPARATED, AND THE SEPARATED PORTION WAS EMBEDDED WITH AN UNSPECIFIED STENT. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT IS FINE. THERE WERE 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 12741107 ↗
• MalfunctionOct 26, 2020Difficult to Remove; Difficult to Remove

  THIS IS BEING FILED ON THE FIRST INFILTRAC GUIDEWIRE USED IN THIS PATIENT. IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DURING A PHYSICIAN PREFERENCE TESTING. THE INFILTRAC GUIDE WIRE SUCCESSFULLY PENETRATED THE CTO LUMEN. DURING REMOVAL OF THE INFILTRAC GUIDE WIRE, IT WAS DIFFICULT TO REMOVE DUE TO THE PATIENT ANATOMY. AFTER REMOVAL OF THE WIRE FROM THE NON-ABBOTT BALLOON DILATATION CATHETER (BDC), CONTRAST WAS NOTED TO BE STAINING ON THE FLUOROSCOPY, SIGNALING A RUPTURED BDC. THE PHYSICIAN SUSPECTS THAT THE TIP OF THE INFILTRAC GUIDE WIRE CAUSED THE BALLOON RUPTURE. AFTER REMOVAL OF THE GUIDE WIRE, THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. ANOTHER INFILTRAC WAS USED TO COMPLETE THE PROCEDURE. THE SECOND INFILTRAC WAS ALSO DIFFICULT TO RETRACT, BUT IT WAS REMOVED WITHOUT INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736135 ↗
• MalfunctionOct 21, 2020Difficult to Remove; Difficult to Remove

  THIS IS BEING FILED ON THE SECOND INFILTRAC GUIDEWIRE USED IN THIS PATIENT. IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DURING A PHYSICIAN PREFERENCE TESTING. THE INFILTRAC GUIDE WIRE SUCCESSFULLY PENETRATED THE CTO LUMEN. DURING REMOVAL OF THE INFILTRAC GUIDE WIRE, IT WAS DIFFICULT TO REMOVE DUE TO THE PATIENT ANATOMY. AFTER REMOVAL OF THE WIRE FROM THE NON-ABBOTT BALLOON DILATATION CATHETER (BDC), CONTRAST WAS NOTED TO BE STAINING ON THE FLUOROSCOPY, SIGNALING A RUPTURED BDC. THE PHYSICIAN SUSPECTS THAT THE TIP OF THE INFILTRAC GUIDE WIRE CAUSED THE BALLOON RUPTURE. AFTER REMOVAL OF THE GUIDE WIRE, THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. ANOTHER INFILTRAC WAS USED TO COMPLETE THE PROCEDURE. THE SECOND INFILTRAC WAS ALSO DIFFICULT TO RETRACT, BUT IT WAS REMOVED WITHOUT INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715515 ↗