TrailBlazer™ SC-014-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000104740), received between Oct 13, 2022 and Nov 15, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED THAT WHILE A TRAILBLAZER CATHETER WAS BEEN USED A 3 INCH SEGMENT OF THE TIP BROKE OFF WHILE THE SURGEONS WERE TRYING TO INSERT IT INTO THE SHEATH, THE SURGEONS WERE ABLE TO RETRIEVE THE ENTIRE CATHETER SAFELY.

  Patient problems: Insufficient Information

  MAUDE report 15798105 ↗
• InjuryOct 13, 2022Break

  WHILE USING A TRAILBLAZER CATHETER FROM EV3, APPROXIMATELY A 3-INCH SEGMENT OF THE TIP BROKE OFF WHILE THE SURGEONS WERE TRYING TO INSERT IT INTO THE SHEATH. THE SURGEONS WERE ABLE TO RETRIEVE THE ENTIRE CATHETER. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15605917 ↗

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-