TrailBlazerRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of TrailBlazer by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2024 and Mar 25, 2026 — classified as 3 injuries, 23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TrailBlazer problems
Device problems
- Device Markings/Labelling Problem20
- Detachment of Device or Device Component6
- Difficult to Advance1
- Difficult to Insert1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information1
TrailBlazer models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TrailBlazer™ ASC-018-150Catheter, percutaneous21 reports
- TrailBlazer™ SC-035-135Catheter, percutaneous3 reports
- TrailBlazer™ SC-014-150Catheter, percutaneous1 report
- TrailBlazer™ ASC-014-150Catheter, percutaneous1 report
Recent TrailBlazer adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING THE TRAILBLAZER ANGLED SUPPORT CATHETER IN THE TIBIAL/POPLITEAL TRUNK, DETACHMENT/FRACTURE OF THE DEVICE TIP OCCURRED. THE TIP WAS BROKEN BUT REMAINED ATTACHED TO THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685666 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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