TrailBlazer™ SC-018-090 (UDI 00763000104764)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000104764), received between Mar 26, 2021 and May 25, 2023 — classified as 2 malfunctions.

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.

• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER WAS BEING USED DURING TREATMENT OF A CALCIFIED LESION IN THE MID POSTERIOR TIBIAL ARTERY. THE ARTERY WAS MODERATELY CALCIFIED WITH NO TORTUOSITY. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING REINSERTION THE PHYSICIAN OBSERVED THAT THE TIP WAS DETACHED. THE TIP WAS FOUND TO BE DETACHED OUTSIDE OF THE PATIENT, WHEN PREPARING FOR RE-INSERTION OF TRAILBLAZER. ANOTHER TRAILBLAZER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000798 ↗
• MalfunctionMar 26, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE TRAILBLAZER GUIDE CATHETER ALONG WITH 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID RENAL ARTERY WITH 90%. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 20MM RESPECTIVELY. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CATHETER BROKE WHILE BEING REMOVED FROM A VERY CALCIFIED RENAL ARTERY. THE CATHETER SEGMENTS/FRAGMENTS WERE NOT RETRIEVED. THE TIP OF THE TRAILBLAZER BROKE OFF AND WAS LEFT IN THE LEFT RENAL ARTERY. THE RENAL ARTERY WAS STENTED TO COMPLETE THE PROCEDURE. STENT WAS NOT IMPLANTED TO CAGE CATHETER FRAGMENT AGAINST THE VESSEL WALL. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE DETACHED FRAGMENT. THE ORIGINAL GOAL OF THE CASE WAS TO EMBOLIZE AN ARTERY SO THE PHYSICIAN COULD PROCEED WITH A CRYO PROCEDURE THE FOLLOWING DAY THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575233 ↗

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-