TrailBlazer™ SC-018-135 (UDI 00763000104771)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000104771), received between Nov 2, 2020 and Jan 22, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K092299); they may or may not involve this specific model.

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.

• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE TRAILBLAZER SUPPORT CATHETER FOR PATIENT TREATMENT. THE PATIENT UNDERWENT LOWER EXTREMITY ARTERIAL STENT IMPLANTATION AND ANGIOGRAPHY UNDER MAC. DURING THE PROCEDURE THE SUPPORT CATHETER WAS USED TO PASS THE GUIDE WIRE, THE TIP OF THE SUPPORT CATHETER BROKE PASSING THROUGH THE GUIDEWIRE AND THE SURGERY COULD NOT BE CONTINUED. THE DEVICE WAS REPLACED WITH ANOTHER SUPPORT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206222 ↗
• InjuryJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A TRAILBLAZER SUPPORT CATHETER FOR TREATMENT OF A SOFT TISSUE LESION IN THE POSTERIOR TIBIAL ARTERY. THERE WAS NOT CALCIFICATION OR TORTUOSITY. THE IFU WAS FOLLOWED. IT WAS REPORTED A BALLOON DILATATION OPERATION WAS PERFORMED ON THE INFRAPOPLITEAL ARTERY. DURING THE OPERATION, IT WAS ADVANCED TO THE LOCATION OF THE ANTERIOR TIBIAL ARTERY LESION, A GUIDEWIRE WAS INSERTED, AND THE SUPPORT CATHETER WAS WITHDRAWN. DURING THE WITHDRAWAL PROCESS, THE CATHETER BROKE AND A PART OF IT REMAINED IN THE BLOOD VESSEL. THE SURGEON PUNCTURED AND WENT UPPER ON THE DORSALIS PEDIS ARTERY AND USED A CATCHER TO CATCH THE BROKEN PART AND REMOVED IT FROM THE BODY.

  Patient problems: Insufficient Information

  MAUDE report 19466045 ↗
• InjuryFeb 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF AN 80MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE COMMON ILIAC ARTERY. THE ARTERY DIAMETER WAS 7MM. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS SEVERE. THE VESSEL WAS NOT PRE OR POST DILATED. THE IFU WAS FOLLOWED. A 7FR SHEATH AND A NITREX GUIDEWIRE WERE USED. THE 0.018 INCH NITREX WIRE WAS ABLE TO PASS THROUGH A SMALL CHANNEL. UPON TRYING TO PASS A .018 INCH TRAILBLAZER, IT WAS REPORTED THE TIP OF THE TRAILBLAZER BECAME LODGED IN THE SEVERELY CALCIFIED PLAQUE, AND THE TIP OF THE CATHETER BROKE OFF WHEN THE PHYSICIAN TRIED TO REMOVE IT. APPROXIMATELY 10 MM OF CATHETER WAS TRAPPED IN THE OCCLUDED VESSEL. THE PHYSICIAN HAD ATTEMPTED TO SNARE THE BROKEN PIECE OF CATHETER, BUT AFTER MULTIPLE ATTEMPTS FOUND THE SECTION WAS IRRETRIEVABLE AND IN A CTO, WHICH POSED NO THREAT OR HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16442294 ↗
• MalfunctionApr 12, 2021Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  PHYSICIAN USED A TRAILBLAZER DEVICE DURING PATIENT TREATMENT. THE DEVICE WAS INTRODUCED IN THE PATIENT WITH A GUIDE. IT IS REPORTED DURING THE EXTRACTION THE DEVICE BECAME BROKEN. THE DETACHED PART DID NOT REMAIN IN THE PATIENT AND WAS FOUND ON THE GUIDE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647273 ↗
• MalfunctionNov 2, 2020Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A 6FR NON-MEDTRONIC SHEATH AND 0.018 NITREX WIRE DURING TREATMENT OF A 100MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY IS REPORTED. ARTERY DIAMETER REPORTED AS 7MM. IFU WAS FOLLOWED. DAMAGED COMPONENTS RELATED TO THE TRAILBLAZER DEVICE ARE REPORTED DURING THE PROCEDURE. IT IS REPORTED THE NITREX WIRE CAME OUT OF THE TRAILBLAZER PROXIMAL TO THE DISTAL END OF THE CATHETER. NO BREAKS ARE REPORTED. THE TRAILBLAZER WAS REMOVED FROM THE PATIENT AND REPLACED. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10770069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092299. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-2010 · Nov 6, 2009 · Terminated
  TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-