TrailBlazer™ SC-014-150 (UDI 00763000104757)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000104757), received between Mar 2, 2023 and May 1, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A 6FR NON-MEDTRONIC SHEATH AND AN 014 NON-MEDTRONIC GUIDEWIRE DURING PROCEDURE TO TREAT THE PATIENTS RIGHT AND LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION DEVICE WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED A PORTION OF THE SHAFT DETACHED IN THE PATIENTS VESSEL. THE DETACHED PORTION WAS STUCK ON THE GUIDEWIRE AND REMOVED ONCE THE WIRE WAS PULLED OUT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220481 ↗
• InjuryMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING THE TREATMENT OF A PLAQUE LESION WITH 95% STENOSIS IN THE MID RIGHT POSTERIOR TIBIAL ARTERY. THERE WAS MODERATE CALCIFICATION AND MILD TORTUOSITY. A 4FR NON MEDTRONIC SHEATH AND A 0.014" 300CM NON MEDTRONIC (COMMAND) GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE IFU WAS FOLLOWED. THE PHYSICIAN TRIED TO CROSS A MID SUPERFICIAL FEMORAL ARTERY HEAVILY CALCIFIED LESION BY GOING FROM THE RIGHT COMMON FEMORAL ACCESS. THE WIRE WOULD NOT CROSS AND ENDED UP PERFORATING THE VESSEL. AT THAT TIME PEDAL ACCESS WAS USED TO CROSS THE LESION. THE WIRE WOULD NOT CROSS ON ITS OWN AND THE TRAILBLAZER WAS USED TO ASSIST THE WIRE TO CROSS THE LESION.IT WAS REPORTED THE .014 COMMAND WIRE WAS PLACED THROUGH THE SHEATH TO THE LESION SITE. THE .014 TRAILBLAZER WAS THEN PLACED OVER THE WIRE TO CROSS THE LESION. ONCE THE COMMAND WIRE WAS ACROSS THE LESION, THE TRAILBLAZER WAS WITHDRAWN. IT WAS OBSERVED ON AN IMAGE THAT THE MARKERS OF THE TRAILBLAZER REMAINED IN THE VESSEL. THE CATHETER HAD BROKEN IN TWO WITH SEGMENTS FRAGMENTS OF THE CATHETER STUCK ON THE GUIDEWIRE. AN OPEN APPROACH WAS USED TO REMOVE THE

  Patient problems: Insufficient Information

  MAUDE report 16884735 ↗
• MalfunctionMar 2, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  A TRAILBLAZER CATHETER WAS BEING USED FOR THE TREATMENT OF A 100MM CALCIFIED PLAQUE LESION WITH 50% STENOSIS IN THE DISTAL REGION OF THE RIGHT ANTERIOR TIBIAL ARTERY (AT) AND PEDAL ARTERY. THE ARTERY DIAMETER WAS 2-3MM WITH SEVERE CALCIFICATION AND MILD TORTUOSITY. A 0.014 NON-MEDTRONIC (MONGO) GUIDEWIRE WAS USED. THE GUIDEWIRE WAS HYDRATED AT PREPARATION. THE VESSEL WAS NOT PRE OR POST DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED WHEN THE PHYSICIAN ATTEMPTING TO ADVANCE THE WIRE AND THE CATHETER THROUGH PEDAL/AT ACCESS THE CATHETER LOCKED UP ON THE WIRE. DEVICE WAS NOT ADVANCED OVER BIFURCATION, WAS FROM PEDAL ACCESS. THE PHYSICIAN TRIED TO REMOVE THE CATHETER AND THE CATHETER STRETCHED AND SEPARATED. DETACHED DEVICE REMOVED IN TANDEM. THE WIRE AND CATHETER WERE REMOVED AS A UNIT. ANOTHER CATHETER AND WIRE WERE ADVANCED. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465457 ↗

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-