TruePath™ H74939208181650Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729820284), received between Mar 15, 2018 and Aug 27, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Break; Failure to Advance; Material Integrity Problem; Break; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL AT THE TIP PEELED OFF. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A TRUEPATH CHRONIC TOTAL OCCLUSION DEVICE WAS SELECTED FOR USE. DURING PROCEDURE, IT FAILED TO ADVANCE TO ITS DESIRED DIRECTION. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COATING OF THE COIL AT THE TIP PEELED OFF AND BECAME CHIPPED. THE ABRASION WAS DUE TO THE DEVICE BEING STUCK TO THE SEVERELY CALCIFIED LESION, AND RESISTANCE WAS FELT AS PULLING ANG PUSHING THAT CAUSED THE ABRASION. ALSO, SOMETHING HAIRLIKE ON THE TIP WAS OBSERVED WHICH APPEARED TO BE UNRAVELED COIL MATERIAL AT THE TIP. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935767 ↗
• MalfunctionMar 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP LOOKED SEPARATED. THE CHRONIC TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A TRUEPATH DEVICE WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE WAS PUSHED AND PULLED IN ACCORDANCE WITH THE CONTROL UNIT. CONSEQUENTLY, IT SEEMED LIKE THE GOLD TIP HOUSING OF THE DEVICE WAS SEPARATED UNDER FLUOROSCOPY. HOWEVER, THE RADIOPAQUE TIP OF THE DEVICE CANNOT BE SEEN ON THE SCREEN BECAUSE IT WAS TRANSPARENT. THE DEVICE WAS THEN SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THERE WERE NO FRAGMENTS OF THE DEVICE LEFT INSIDE. NO COMPLICATIONS REPORTED AND THERE WERE NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433550 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A TRUEPATH CTO DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TRYING TO CROSS THE OCCLUDED LESION, IT WAS NOTED THAT THE CATHETER SHAFT PARTIALLY FRACTURED. THE DEVICE WAS REMOVED FROM PATIENT'S BODY BEFORE IT BECAME COMPLETELY SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370290 ↗
• MalfunctionFeb 1, 2019Activation Problem; Activation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-JAN-2019. IT WAS REPORTED THAT THE DEVICE NO LONGER FUNCTIONED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A TRUEPATH WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE NO LONGER FUNCTIONED AS IT STOPPED ACTIVATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DRIVE SHAFT WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297698 ↗
• MalfunctionDec 11, 2018Device Alarm System; Device Alarm System

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-NOV-2018 IT WAS REPORTED THAT THE THREE LAMPS LIT ON. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT FEMORAL ARTERY. A TRUEPATH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS DELIVERED AFTER TIP SHAPING; HOWEVER, THREE LAMPS IMMEDIATELY LIT ON. THE DEVICE WAS RECONNECTED AND THE TIP PART WAS WASHED WITH SALINE, BUT THE ISSUE WAS NOT RESOLVED. THE TIP OF THE DEVICE WAS NOT ROTATING BUT THE ENTIRE DISTAL SECTION NEAR THE TIP LOOKED LIKE ROTATING, WELTERING, AND TWISTING. THERE WERE SOUND OF RESISTANCE WHILE ROTATING AND THE NOISE WAS DIFFERENT THAN USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DRIVE SHAFT WAS SEPARATED FROM THE MOTOR. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A TRUEPATH DEVICE. THE CONTROL UNIT, MOTOR HOUSING, WORKING LENGTH, TIP HOUSING/TIP WERE MICROSCOPICALLY EXAMINED. THE COILS AT THE PROXIMAL PORTION ON OF THE TIP WAS STRETCHED. FUNCTIONAL TESTING WAS PERFORMED BY TURNING ON THE DEVICE. THE DEVICE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151186 ↗
• MalfunctionDec 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE. THE CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A TRUEPATH WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED UNDER FLUOROSCOPY THAT PART OF THE RADIOPAQUE MARKER OF THE TIP WAS THIN AT ABOUT 5MM WHILE MANIPULATING. IT WAS THEN JUDGED TO BE BROKEN AND WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE DEVICE WAS VISUALLY INSPECTED OUTSIDE THE PATIENT'S BODY AND THERE WERE NO ABNORMALITIES OBSERVED. THE PROCEDURE WAS COMPLETED WIT ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142085 ↗
• MalfunctionNov 6, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE LESION. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERIOR FEMORAL ARTERY. WHILE ADVANCING THE DEVICE IN THE CHRONIC TOTAL OCCLUSION, IT BECAME STUCK IN THE LESION. IT WAS RELEASED BY PUSHING AND PULLING THE DEVICE SEVERAL TIMES; AFTER THIS THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT. IT WAS CONFIRMED THAT NO DETACHMENT OF THE DEVICE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043084 ↗
• MalfunctionOct 30, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 100% STENOSED MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A TRUEPATH WAS SELECTED FOR USE AND DURING REMOVAL A THREAD-LIKE FRAGMENT WAS OBSERVED AND THE TIP WAS STRETCHED AND DETACHED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021141 ↗
• MalfunctionSep 18, 2018Failure to Advance; Unintended Movement; Failure to Advance; Unintended Movement

  IT WAS REPORTED THAT THE RADIOPAQUE (RO) MARKER OF THE TIP WAS MOVED. THE CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED AT SEVERELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL THAT HAD AN S SHAPE BEND. A TRUEPATH CTO DEVICE WAS USED TO TREAT THE TARGET LESION. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION AND AN ATTEMPT WAS MADE TO CROSS THE LESION. A RUBICON GUIDE CATHETER WAS THEN INSERTED BUT COULD ONLY PASS THROUGH THE MIDDLE OF THE LESION AREA AND THE BACK UP BECAME INSUFFICIENT. THEN, THE TRUEPATH WAS ADVANCED SLOWLY. HOWEVER, IT WAS NOTED THAT THE DISTANCE BETWEEN THE RO MARKER OF THE TIP AND THE TIP DIAMOND PART BECAME INCREASED AND FAILED TO ADVANCE FROM THERE. IT WAS THEN NOTED THAT THE TIP OF THE CATHETER WAS DAMAGED WITH THE RO MARKER MOVED, SO USAGE OF TRUEPATH WAS STOPPED. A DISTANCE BETWEEN THE TIP AND RADIOPAQUE SECTION LOOKED TO BE SEPARATED ONCE UNDER ANGIOGRAPHY, BUT IT BECAME NORMAL STATE WHEN THE DEVICE WAS PULLED PROXIMALLY. CONTRALATERAL APPROACH USING NON BSC GUIDEWIRE ADVANCED; HOWEVER, THE MICRO CATHETER DID NOT ADVANCE. DISTAL PUNCTURE WAS ADDED AND THE SAME GUIDEWIRE WAS ADVANCED BY RETROGRADE AND IT SUCCESSFULLY CROSSED THE LESION. DILATION W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886431 ↗
• MalfunctionAug 31, 2018Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE SHAFT COULD NOT BE SEEN ON X-RAY VASCULAR ACCESS WAS OBTAINED UTILIZING CROSS OVER APPROACH. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A TRUEPATH WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE WAS USED IN COMBINATION WITH SUPPORT BY CROSS OVER APPROACH AT THE CTO LESION IN SFA OF ABOUT 15CM AND THE RADIOPAQUE MARKER AREA WAS PARTIALLY PENETRATED/WENT THROUGH. HOWEVER, THE SHAFT COULD NOT BE SEEN BECAUSE OF THE VIEWING ANGLE OF X-RAY; MADE IT DIFFICULT TO SEE. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUEPATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836890 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-FEB-2018. IT WAS REPORTED THAT THE TIP FAILED TO ROTATE. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A TRUEPATH¿ CTO DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INSIDE THE PATIENT'S BODY, IT WAS NOTED THAT THE TIP OF THE TRUEPATH¿ DEVICE STOPPED ROTATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE FIBERS WRAPPED AROUND THE TIP AND THE OUTER SHAFT ROTATES WITH THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7343005 ↗