TrailBlazer™ SC-014-150 (UDI 00763000762759)Recalls & reported problems
Medtronic, Inc. · PS SC-014-150 TRAILBLAZER V06 · Class 2
All models of TrailBlazer (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000762759), received between Dec 9, 2024 and Dec 9, 2024 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
A TRAILBLAZER SUPPORT CATHETER WAS INTENDED TO BE USED FOR TREATMENT OF THE ANTERIOR TIBIAL ARTERY. A NON MEDTRONIC 0.014 GUIDEWIRE WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED THERE WAS SEVERE RESISTANCE WHEN ADVANCING THE GUIDEWIRE, THE DEVICE WAS INSIDE THE PATIENT WHEN THE ISSUE OCCURRED. THE DEVICE WAS SAFELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878901 ↗
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 · TerminatedTrailBlazer 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-
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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