TrailBlazer™ SC-018-150 (UDI 00821684058015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684058015), received between Aug 11, 2017 and Mar 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• InjuryMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN WAS USING A TRAILBLAZER SUPPORT CATHETER IN A PROCEDURE. IT WAS REPORTED THAT A PATIENT HAD DISTAL AORTOGRAPHY WITH RUNOFF, LEFT LOWER EXTREMITY ANGIOGRAPHY, ANGIOPLASTY OF THE LEFT ANTERIOR TIBIAL ARTERY. THIS PROCEDURE WAS COMPLEX AND REQUIRED MULTI-SITE ACCESS: RIGHT COMMON FEMORAL ARTERY IN ADDITION TO ULTRASOUND-GUIDED ACCESS TO THE LEFT DISTAL ANTERIOR TIBIAL ARTERY. THE RIGHT FEMORAL ARTERY WAS ACCESSED UTILIZING THE MICROPUNCTURE TECHNIQUE. A 5-FRENCH NON-MEDTRONIC (OMNIFLUSH) CATHETER AND A 6-FRENCH COOK SHEATH WERE USED. THE SHEATH WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY. ANGIOGRAPHY PERFORMED. THE 0.035 TRAILBLAZER SUPPORT CATHETER BECAME STUCK ON THE NON-MEDTRONIC 0.035 (HALBERD) GUIDEWIRE. THE CATHETER GUIDEWIRE WAS EXTERNALIZED THROUGH THE DISTAL ANTERIOR TIBIAL ACCESS SITE. IN PULLING ON THE CATHETER, THE DISTAL TIP OF THE SUPPORT CATHETER WAS BROKEN OFF. THE SUPPORT CATHETER WAS SUBSEQUENTLY DISLODGED FROM THE GUIDEWIRE AND REMOVED FROM THE BODY WITHOUT ANY OTHER DIFFICULTY. THE PROCEDURE CONTINUED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8393876 ↗
• InjuryJul 20, 2018Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT THE PROCEDURE WAS DIFFICULT DUE TO THE SEVERITY OF ARTERIAL CALCIFICATION. WHEN PASSING THE DEVICE THROUGH THE CALCIFICATION, THE MICRO CATHETER ON THE WIRE WAS DETACHED ON THE PROXIMAL END. THE DETACHED END OF THE MICRO CATHETER WAS RETRIEVED USING A NON-MDT SNARE CAPTURE DEVICE. THE WIRE AND THE CATHETER WERE ABLE TO BE REMOVED AND REPLACED. NOTHING WAS LEFT IN THE BODY AND THE PATIENT DID NOT SUSTAIN ANY HARM AS A RESULT.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 7706209 ↗
• MalfunctionAug 11, 2017Stretched; Material Deformation; Stretched; Material Deformation

  PHYSICIAN USED A TRAILBLAZER SUPPORT CATHETER FOR TREATMENT OF A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY WHICH EXHIBITED CTO (CHRONIC TOTAL OCCLUSION ¿ 100%). THERE WAS LITTLE DEGREE OF TORTUOSITY/CALCIFICATION. IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN ADVANCING THE GUIDEWITE THROUGH THE SHEATH. AFTER A FEW ADVANCEMENTS WERE ATTEMPTED BUT FAILED, THE PHYSICIAN DECIDED TO PULL BACK BOTH THE WIRE, TRAILBLAZER CATHETER AND 4FR SHEATH OUT OF PATIENT'S BODY. IT WAS THEN OBSERVED THAT A SECTION OF THE TRAILBLAZER, BETWEEN THE MIDDLE AND PROXIMAL RADIOPAQUE MARKER, WAS ELONGATED (ALMOST BROKEN APART). NO MISSING PART WAS LEFT IN THE PATIENT'S BODY. THE PHYSICIAN THEN REPLACED THE BROKEN TRAILBLAZER WITH A NEW ONE OF THE SAME SIZE AND IT PASSED THROUGH THE 4FR SHEATH SMOOTHLY IN ORDER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787372 ↗

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-