TrailBlazer™ SC-035-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000104825), received between Feb 28, 2020 and Nov 29, 2021 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT IS REPORTED DURING A PROCEDURE THE TRAILBLAZER DEVICE POSSIBLY SEPARATED IN THE POPLITEAL ARTERY OF THE PATIENT. IFU WAS FOLLOWED. PHYSICIAN WAS TRYING TO CROSS A CTO TO LOWER EXTREMITY. PHYSICIAN HAD A HARD TIME REMOVING THE TRAILBLAZER OVER THE WIRE AND HAD TO FORCE IT OUT. PHYSICIAN THEN NOTICED THAT MARKERS WERE DETACHED FROM THE CATHETER VIA FLUOROSCOPY, CHECKED THE CATHETER AND EVERYTHING ELSE WAS INTACT. PHYSICIAN TRIED USING A SNARE TO CAPTURE THE MARKERS BUT WAS NOT SUCCESSFUL. PHYSICIAN CONSULTED VASCULAR SURGEON FOR HELP, PROCEDURE WAS REVIEWED AND AGREED PATIENT REQUIRES A BYPASS SURGERY. PHYSICIAN AND VASCULAR SURGEON AGREED THAT THE MARKERS SHOULD BE LEFT ALONE SINCE THEY WERE NOT OBSTRUCTING THE BLOOD FLOW. RADIOPAQUE MARKERS WERE LEFT IN SMALL COLLATERALS OF THE POPLITEAL ARTERY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12881213 ↗
• InjuryOct 15, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICAL USED A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S MID RIGHT COMMON ILIAC ARTERY. SEVERE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. DAMAGED COMPONENTS ARE REPORTED DURING THE PROCEDURE. IT IS REPORTED DURING WITHDRAWAL OF THE DEVICE, THE PHYSICIAN FELT SEVERE RESISTANCE. THE PHYSICIAN ATTEMPTED TO MANOEUVRE THE CATHETER FORWARD AND BACK, BUT IT WOULD NOT MOVE. THE CATHETER HAD CROSSED THE BIFURCATION OF THE COMMON ILIAC AND WAS PLACED IN BOTH THE COMMON ILIAC AND EXTERNAL ILIAC. ONA FURTHER WITHDRAWAL ATTEMPT THE CATHETER IS REPORTED TO HAVE SNAPPED INTO 2 SEGMENTS. ON REMOVAL ALL THREE DISTAL MARKERS, AROUND 100MM OF THE CATHETER STUCK IN THE COMMON AND EXTERNAL ILIAC. NO CATHETER FRAGMENTS ARE REPORTED TO HAVE REMAINED ON THE GUIDEWIRE. THE DETACHED PORTION WAS NOT REMOVED. THE ENTIRE REGION WAS STENTED IN ORDER TO TRAP THE TIP OF THE CATHETER IN THE EXTERNAL ILIAC/COMMON ILIAC. NO FURTHER INJURY REPORTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683480 ↗
• MalfunctionFeb 28, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN USED A TRAILBLAZER DEVICE DURING PATIENT TREATMENT. IT IS REPORTED THE TRAILBLAZER CATHETER BECAME ADHERENT TO THE NON-MEDTRONIC WIRE WHILE IN THE PATIENT¿S VESSEL, CAUSING BOTH TO BE UNABLE TO MOVE FREELY. WHEN TRYING TO PULL THE WIRE BACK, IT SNAPPED THE TIP OFF THE CATHETER WITHIN ITSELF. THE CATHETER AND WIRE SYSTEM WERE THEN PULLED OUT IN THEIR ENTIRETY, LEAVING NOTHING BEHIND IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768963 ↗

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-