TrailBlazer™ SC-018-135 (UDI 00821684058008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684058008), received between Jun 10, 2018 and Dec 22, 2020 — classified as 2 injuries, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER DURING PROCEDURE TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DISTAL TIP WAS SEPARATED FROM THE CATHETER AND COULD NOT BE REMOVED FROM THE VESSEL. AN EVERFLEX STENT WAS IMPLANTED TO CAGE THE DETACHED TIP AGAINST THE VESSEL WALL. NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053750 ↗
• MalfunctionDec 7, 2018Material Puncture/Hole; Material Puncture/Hole

  PHYSICIAN USED A TRAILBLAZER WITH A 6F X 45 CM NON-MEDTRONIC SHEATH AND 0.018 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A FIBROUS CTO (CHRONIC TOTAL OCCLUSION -100%) IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED. IT IS REPORTED THE WIRE APPEARED TO HAVE PERFORATED THE TRAILBLAZER. FROM ANGIOGRAPHIC APPEARANCE, THE WIRE PROLAPSED IN THE ARTERY OUTSIDE OF THE SUPPORT CATHETER. THE WIRE AND TRAILBLAZER WERE BOTH REMOVED FROM THE PATIENT WITH NO ISSUES NOTED. THE PROCEDURE WAS ABORTED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141650 ↗
• MalfunctionJul 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A NITREX GUIDEWIRE (0.018" 300CM) AND A TRAILBLAZER (0.018" 135CM) WITH A 6FR NON-MEDTRONIC SHEATH TO THE LEFT MID POSTERIOR TIBIAL ARTERY WITH 90% STENOSIS. THE LESION LENGTH WAS REPORTED AS 65MM. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A 2.5X80MM BALLOON AT 8ATM. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENTS ANATOMY. THE DEVICES WERE PREPPED AS PER THE IFU. DURING THE PROCEDURE THE GUIDEWIRE WAS INFLATED AND SQUEEZED INTO THE SUPPORT CATHETER. THE STRUCTURE OF THE GUIDEWIRE WAS REPORTED TO BE ¿BROKEN¿, SO BOTH DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-MEDTRONIC 0,014¿ 300CM GUIDEWIRE AND A 0,014¿ 150CM TRAILBLAZER. THE LESION WAS POST DILATED WITH A 4X80MM BALLOON AT 8ATM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662445 ↗
• InjuryJun 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TRAILBLAZER CATHETER BROKE AND THAT A PIECE OF CATHETER REMAINED IN THE PATIENT BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7585465 ↗

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-