TrailBlazer™ ASC-018-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000770341), received between Mar 10, 2025 and Mar 19, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (20 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE TRAILBLAZER SUPPORT CATHETER, A LABELLING AND PACKAGING ISSUE WAS IDENTIFIED IN WHICH BOTH THE PACKAGING AND HUB STATED THE CATHETER WAS 150CM IN LENGTH, BUT THE ACTUAL CATHETERS INSIDE WERE MUCH SHORTER. STERILE PACKAGINGWAS INTACT. THE DEVICE WAS NOT USED IN A PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636909 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERIAL PROCEDURE INVOLVING THE TRAILBLAZER SUPPORT CATHETER, THE DEVICE TIP DETACHED AND FRACTURED WITHIN THE SHEATH, RESULTING IN A FIVE-MINUTE DELAY IN SURGERY TO REMOVE THE TIP WITHIN THE SHEATH. THE PROCEDURE INVOLVED THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY AT THE MID LOCATION. THE DETACHED TIP WAS SUCCESSFULLY REMOVED FROM THE SHEATH, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018507 ↗
• MalfunctionJan 9, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE TRAILBLAZER SUPPORT CATHETER, A LABELLING AND PACKAGING ISSUE WAS IDENTIFIED IN WHICH BOTH THE PACKAGING AND HUB STATED THE CATHETER WAS 150CM IN LENGTH, BUT THE ACTUAL CATHETERS INSIDE WERE MUCH SHORTER. STERILE PACKAGINGWAS INTACT. THE DEVICE WAS NOT USED IN A PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018247 ↗
• MalfunctionNov 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ANGLED TRAILBLAZER SUPPORT CATHETER MEASURED TO BE 100CM INSTEAD OF 150CM. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540217 ↗
• MalfunctionSep 8, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE TRAILBLAZER SUPPORT CATHETER, A LABELLING AND PACKAGING ISSUE WAS IDENTIFIED, WITH ALLEGATIONS OF THE WRONG PRODUCT AND WRONG LENGTH. THE BOX AND HUB WERE LABELLED AS .018 150CM ANGLED TRAILBLAZER, BUT THE ACTUAL CATHETER LENGTH APPEARED TO BE 65 OR 90CM. THE ISSUE WAS DISCOVERED BEFORE THE DEVICE WAS USED IN A PATIENT. STERILE PACKAGING INTACT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991797 ↗
• MalfunctionSep 8, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE TRAILBLAZER SUPPORT CATHETER, A LABELLING AND PACKAGING ISSUE WAS IDENTIFIED, WITH ALLEGATIONS OF THE WRONG PRODUCT AND WRONG LENGTH. THE BOX AND HUB WERE LABELLED AS .018 150CM ANGLED TRAILBLAZER, BUT THE ACTUAL CATHETER LENGTH APPEARED TO BE 65 OR 90CM. THE ISSUE WAS DISCOVERED BEFORE THE DEVICE WAS USED IN A PATIENT. STERILE PACKAGING INTACT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991647 ↗
• MalfunctionApr 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER CATHETER. IN THE PACKAGE IT WAS A 90CM CATHETER AND WAS LABEL A 150CM. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826903 ↗
• MalfunctionApr 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER CATHETER. IN THE PACKAGE IT WAS A 90CM CATHETER AND WAS LABEL A 150CM. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826889 ↗
• MalfunctionApr 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER CATHETER. IN THE PACKAGE IT WAS A 90CM CATHETER AND WAS LABEL A 150CM. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826863 ↗
• MalfunctionApr 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER CATHETER. IN THE PACKAGE IT WAS A 90CM CATHETER AND WAS LABEL A 150CM. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826822 ↗
• MalfunctionApr 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER CATHETER. IN THE PACKAGE IT WAS A 90CM CATHETER AND WAS LABEL A 150CM. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826807 ↗
• MalfunctionApr 1, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TRAILBLAZER ANGLED CATHETER, ISSUES WERE NOTED PRIOR TO USE WITH THE DEVICE BEING MUCH SHORTER THAN THE 150CM SIZE INDICATED ON THE LABEL. THE PROCEDURE WAS ASSOCIATED WITH THE PERIPHERAL ARTERIES, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND TIBIAL/POPLITEAL TRUNK. PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. A NEW DEVICE, NOT FROM MEDTRONIC, WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741269 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558440 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558378 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018 X 150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558364 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558353 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558351 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558331 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558282 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558261 ↗
• MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018 X 150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558253 ↗