TrailBlazer™ Angled ASC-018-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000104696), received between Oct 7, 2020 and Jan 26, 2026 — classified as 5 malfunctions.

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

• MalfunctionJan 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE INVOLVING THE TRAILBLAZER ANGLED CATHETER, A PATIENT WAS TREATED FOR A PLAQUE LESION WITH 70% STENOSIS LOCATED IN THE MID SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY, WHICH EXHIBITED MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE CURVED TIP OF THE CATHETER BROKE INSIDE THE PATIENT'S BODY.THE TIP DID NOT FULLY DETACH FROM THE DEVICE, WAS REMOVED NORMALLY AND SAFELY FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER PRODUCT OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176223 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A TRAILBLAZER TO TREAT A PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS CTO (CHRONIC TOTAL OCCLUSION-100%). 6F TERUMO SHEATH FRENCH WAS USED. A COMAND 18 GUIDEWIRE WAS USED. THE VESSEL WAS PRE-DILATED. IFU WAS FOLLOWED. IT IS REPORTED THAT PROXIMAL END OF SUPPORT CATHETER DETACHED DURING INITIAL ADVANCEMENT. RESISTANCE WAS FELT DURING ADVANCEMENT. PROCEDURE WAS COMPLETED USING A STRAIGHT SUPPORT CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395443 ↗
• MalfunctionDec 15, 2020Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem

  PHYSICIAN INTENDED TO USE AN ANGLED TRAILBLAZER SUPPORT CATHETER DURING LEFT LEG ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA). IT IS REPORTED THE OSTIAL SFA WAS ENGAGED USING THE ANGLED TRAILBLAZER DEVICE AND A NON-MEDTRONIC WIRE. THE PHYSICIAN UPGRADED TO A 0.035 STIFF ANGLED WIRE AND NON-MEDTRONIC SUPPORT CATHETER. IT IS REPORTED THE PHYSICIAN WAS UNABLE TO PASS THE CATHETER BEYOND THE DISTAL SFA AND THE WIRE AND CATHETER WERE CHANGED FOR A NON-MEDTRONIC 0.018 WIRE AND TRAIBLAZER TO MAKE A SECOND ATTEMPT. IT IS REPORTED THE PHYSICIAN STILL HAD TROUBLE AND DECIDED TO PERFORM ANGIOPLASTY OF THE ENTIRE SFA. IT IS REPORTED THE WIRE APPEARED TO BE IN THE LUMEN AT THE POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE TRAILBLAZER BUT DIFFICULTY WAS EXPERIENCED AND DURING THE ADVANCEMENT ATTEMPT THE DEVICE KINKED. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE AND HAD TO REMOVE THE ENTIRE SYSTEM, IT IS REPORTED DURING THE MANIPULATION THE HUB BROKE OFF THE DEVICE. IT IS REPORTED THE WIRES WOULD NOT SLIDE THROUGH THE CATHETER AND FELT STICKY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009973 ↗
• MalfunctionNov 18, 2020Detachment of Device or Device Component; Difficult to Advance; Material Twisted/Bent

  THE OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA) WAS ENGAGED USING 0.46MM TRAILBLAZER ANGLED (MODEL# ASC-018-150) AND ASAHI ASTATO 30 WIRE. DOCTOR UPGRADED TO 0.035" STIFF ANGLED WIRE AND NAVICROSS. DOCTOR WAS UNABLE TO PASS THE CATHETER BEYOND DISTAL SFA AND WIRE/CATHETER WERE CHANGED TO 0.018" V-18 AND TRAILBLAZER WERE USED AS PART OF A SECOND ATTEMPT. DOCTOR CONTINUED TO HAVE DIFFICULT TIME, AND IT WAS DECIDED TO PERFORM AN ANGIOPLASTY OF THE ENTIRE SFA. THE WIRE APPEARED TO BE IN THE LUMEN AT THE POPLITEAL ARTERY. WHEN DOCTOR ADVANCED THE TRAILBLAZER, IT WAS DIFFICULT TO ADVANCE AND AFTER PUSHING THE WIRE, THE TRAILBLAZER KINKED. DOCTOR WAS UNABLE TO REMOVE THE WIRE AND HAD TO TAKE THE WHOLE THING OUT. HUB BROKE OFF DURING MANIPULATIONS. WIRES WOULD NOT SLIDE THROUGH CATHETER - FELT STICKY.

  Patient problems: Insufficient Information

  MAUDE report 10860007 ↗
• MalfunctionOct 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A HAWKONE ATHERECTOMY DEVICE DURING TREATMENT OF A 250MM PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. IFU WAS FOLLOWED. A 4FR SHEATH AND 0.018 NON-MEDTRONIC WIRE WERE USED WITH THE TRAILBLAZER SUPPORT CATHETER. THE CTO WAS CROSSED USING PEDAL ACCESS. AFTER CROSSING THE CTO AND ADVANCING THE 0.018 NON-MEDTRONIC WIRE THROUGH THE FEMORAL SHEATH, IT WAS OBSERVED THE TIP OF THE TRAILBLAZER HAD DETACHED. THE TIP REMAINED ON THE WIRE AND WAS REMOVED WITHOUT FURTHER INTERVENTION. NO RESISTANCE WAS FELT ADVANCING THE CATHETER OR WITHDRAWING IT. DURING USING THE HAWKONE DEVICE WITH A 7FR NON-MEDTRONIC SHEATH, AND 7FR SPIDER FX AFTER COMPLETION OF PRE-DILATION, IT IS REPORTED WIRE WRAP OCCURRED WHEN TRYING TO PULL THE DEVICE OUT OF THE SHEATH. THE WIRE WRAP WAS RESOLVED BUT THE DEVICE WAS STILL DIFFICULT TO REMOVE FROM THE SHEATH. UPON REMOVAL THE WIRE LUMEN OF THE HAWKONE DEVICE WAS PULLED OFF. THE WIRE LUMEN PEALED BACK OFF THE HAWK ABOUT 75 %.NO COMPONE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10642178 ↗