TrailBlazer™ SC-018-090 (UDI 00821684057995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684057995), received between Nov 22, 2017 and Jun 8, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER DEVICE WAS USED DURING TREATMENT OF CRITICAL LIMBS ISCHEMIA FOR LOWER EXTREMITY WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF RIGHT POPLITEAL OCCLUSION. IT IS REPORTED THAT THE TRAILBLAZER SUPPORT CATHETER FRACTURED AT THE RADIOPAQUE MARKERS. AN ATTEMPT WAS MADE TO RETRIEVE THE FRACTURED CATHETER WITH A SNARE, BUT PHYSICIAN WAS UNSUCCESSFUL IN GRASPING THE CATHETER TIP. IT IS REPORTED THAT 30MM OF THE CATHETER REMAINS IN THE PATIENT¿S ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7581596 ↗
• InjuryNov 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A TRAILBLAZER CATHETER WITH A NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC 0.018¿ GUIDEWIRE FOR THE TREATMENT OF A 20MM SEVERELY CALCIFIED LESION IN PROXIMAL LOCATION OF THE LEFT ANTERIOR TIBIAL ARTERY OF DIAMETER 3MM. VESSEL REPORTED AS BEING MODERATELY TORTUOUS. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THE LESION WAS CROSSED WITH THE GUIDEWIRE BUT PHYSICIAN WAS UNSUCCESSFUL IN CROSSING WITH .018 BALLOON. PHYSICIAN THEN ATTEMPTED TO CROSS WITH AN .018 TRAILBLAZER. WHEN PUSHING THE TRAILBLAZER BACK, IT WAS REPORTED TO HAVE BROKEN AFTER THE FIRST PROXIMAL MARKER. THE CATHETER DID NOT BREAK INTO MULTIPLE SEGMENTS. THE CATHETER SEGMENT WAS NOT STUCK ON THE GUIDEWIRE. THE DETACHED PORTION WAS LEFT IN THE VESSEL AND THE PROCEDURE WAS STOPPED. THE DETACHED PORTION OF THE CATHETER WAS THEN EXPLANTED SURGICALLY. PATIENT STATUS UNKNOWN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7053446 ↗

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-