TrailBlazer™ SC-035-135 (UDI 00763000762810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000762810), received between Apr 18, 2024 and Feb 16, 2026 — classified as 3 injuries.

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

• InjuryFeb 16, 2026Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A LEG REVASCULARIZATION PROCEDURE INVOLVING THE TRAILBLAZER SUPPORT CATHETER, THE PHYSICIAN ENCOUNTERED SEVERE CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PHYSICIAN EXPERIENCED REMOVAL DIFFICULTIES AS THE CATHETER BECAME STUCK AND COULD NOT BE REMOVED. UPON APPLYING ADDITIONAL FORCE, THE CATHETER BROKE. THE PHYSICIAN SUCCESSFULLY SNARED THE CATHETER, ENSURING NOTHING WAS LEFT BEHIND IN THE PATIENT, AND CONFIRMED THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE, RESULTING IN ONLY A MINIMAL DELAY OF A FEW MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343329 ↗
• InjuryDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TRAILBLAZER SUPPORT CATHETER, DETACHMENT OF THE DISTAL 10 CM OF THE CATHETER OCCURRED WITHIN THE VESSEL. THE TARGET LESION WAS LOCATED IN THE MID LEFT COMMON ILIAC ARTERY AND WAS DESCRIBED AS SEVERELY CALCIFIED. THE DETACHED CATHETER COMPONENT WAS REMOVED BY SNARING, AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23838374 ↗
• InjuryApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER DURING PROCEDURE TO TREAT A PLAQUE LESION IN THE PATIENTS RIGHT PROXIMAL S UPERFICIAL 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. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISS UE. EMBOLIC PROTECTION 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 THE TIP OF TRAILBLAZER SUPPORT CATHETER DETACHED IN PATIENTS VESSEL. A SNARE WAS USED TO REMOVE DETACHED COMPONENT. A REPLACEMENT NON-MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132411 ↗

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-