TrailBlazer™ SC-035-090 (UDI 00763000104801)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000104801), received between Sep 18, 2020 and Mar 11, 2026 — 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.

• InjuryMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TRAILBLAZER SUPPORT CATHETER, A PATIENT UNDERWENT INTERVENTION FOR A TARGET LESION CHARACTERIZED BY SEVERE CALCIFICATION, 99% STENOSIS, 100MM LENGTH, AND 7MM DIAMETER, LOCATED IN THE MID LEFT COMMON ILIAC ARTERY. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTAL PORTION OF THE CATHETER DETACHED/FRACTURED AT THE TARGET LESION, RESULTING IN A 30-MINUTE DELAY IN SURGERY. THE DETACHED COMPONENT WAS REMOVED BY SNARING. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24568399 ↗
• MalfunctionMar 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, THE PACKAGING LABEL FOR THE TRAILBLAZER SC-035-090 SUPPORT CATHETER DID NOT MATCH THE ACTUAL PRODUCT INSIDE, WHICH WAS A TRAILBLAZER SC-018-150 AND COULD NOT BE USED. DURING THE PROCEDURE, AFTER PLACING OVER NON-MEDTRONIC SHEATH AND USING A 0.035 NON-MEDTRONIC GUIDEWIRE TO OPEN THE LESION, IT WAS DISCOVERED THAT THE SUPPORT CATHETER UNPACKED WAS NOT AS LABELED. THE LOT NUMBER OF THE INNER PACKAGING AND THE LOT NUMBER OF THE OUTER PACKAGING WERE BOTH B797698. NO DAMAGE NOTED TO THE OUTER PACKAGING, THE STERILE PACKAGING WAS INTACT AND THE DEVICE WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED BY REPLACING THE INCORRECT CATHETER WITH A TRAILBLAZER SC-035-090 SUPPORT CATHETER, WHICH WAS THEN USED WITH A 35 SYSTEM GUIDEWIRE TO OPEN THE LESION AND INSERT A STENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547272 ↗
• InjuryAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLZAER SUPPORT CATHETER WAS BEING USED FOR TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THE CATHETER BROKE IN THE FEMORAL ARTERY AND A LASSO WAS REQUIRED TO REMOVED THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17611404 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A 5MM SHEATH AND 0.035 GUIDEWIRE DURING TREATMENT OF A 200MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED THAT DURING REMOVAL OF THE CATHETER, THE PROXIMAL PORTION OF THE CATHETER BROKE OFF IN THE VERY CALCIFIED SUBINTIMAL VESSEL. THE PROCEDURE WAS ABORTED, AND THE DETACHED PORTION WAS LEFT IN THE PATIENT¿S SUBINTIMAL PORTION OF THE SFA. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; No Consequences Or Impact To Patient

  MAUDE report 10552719 ↗

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-