TrailBlazer™ SC-018-150 (UDI 00763000104788)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000104788), received between Aug 4, 2020 and Dec 17, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY LOWER LIMB PROCEDURE WAS PERFORMED USING AN EXPIRED PS SC-018-150 TRAIL BLAZER SUPPORT CATHETER. THE PHYSICIAN WAS NOT AWARE THE DEVICE HAD EXPIRED PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE DILATION OF THE LESION SITE. INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828316 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE TWO PS SC-018-150 TRAILBLAZER DEVICES TO TREAT A CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS 70%. VESSEL WAS PRE-DIL ATED. DURING THE INSERTION PROCESS, THE CATHETERS BROKE. DUE TO THE PATIENT'S ADVANCED AGE, SURGICAL REMOVAL OF THE CATHETERS WAS NOT FEASIBLE, SO THE CATHETERS WERE LEFT REMAINING INSIDE THE BODY, AND THE SURGERY WAS CONCLUDED IN THIS STATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768586 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE TWO PS SC-018-150 TRAILBLAZER DEVICES TO TREAT A CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. LESION STENOSIS WAS 70%. VESSEL WAS PRE-DIL ATED. DURING THE INSERTION PROCESS, THE CATHETERS BROKE. DUE TO THE PATIENT'S ADVANCED AGE, SURGICAL REMOVAL OF THE CATHETERS WAS NOT FEASIBLE, SO THE CATHETERS WERE LEFT REMAINING INSIDE THE BODY, AND THE SURGERY WAS CONCLUDED IN THIS STATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768554 ↗
• InjuryMar 4, 2024Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A 6FR NON-MEDTRONIC SHEATH AND A 300CM 018 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENTS LEFT PROXIMAL ANTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. A 3X40 NANOCROSS WAS USED FOR VESSEL PRE-DILATION. A 3X210 NANOCROSS WAS USED FOR VESSEL POST-DILATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. PATIENT HAD CALCIFIED LESIONS IN SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, AND ANTERIOR TIBIAL ARTERY. PHYSICIAN WAS NOT ABLE TO CROSS ALL LESIONS FROM THE FEMORAL APPROACH. PEDAL ACCESS WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824759 ↗
• MalfunctionDec 15, 2023Poor Quality Image; Detachment of Device or Device Component; Poor Quality Image; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF A LESION IN THE PATIENTS PROXIMAL COMMON ILIAC ARTERY. LITTLE VESSEL TORTUOSITY AND LITTLE VESSEL CALCIFICATION ARE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE VESSEL WAS PRE AND POST DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. NO RESISTANCE NOTED DURING ADVANCEMENT IT IS REPORTED THAT THE MARKERBAND WAS MISSING; THE MARKER POINT ON THE TIP OF THE PRODUCT WAS MISSING, MAKING IT IMPOSSIBLE TO DEVELOP UNDER RADIOGRAPHY, SO THE SURGERY COULD NOT BE COMPLETED USING THIS PRODUCT. THE MARKERBAND DID NOT DETACH, IT WAS NOT DETACHED TO BLOOD VESSELS, TARGET LESIONS, WITHIN SHEATH AND OTHER PLACES, IT WAS MISSING. POSTOPERATIVE CLINICIAN ANALYSIS SUGGESTED THAT THE MARKER BAND ON THE SUPPORT CATHETER MIGHT BE MISSING DURING PRODUCTION OR TRANSPORTATION. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334308 ↗
• InjuryAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS SEVERELY CALCIFIED AND NO TORTUOSITY. THE DEVICE WAS INSPECTED AND PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE PHYSICIAN TRIED TO PASS THE STENOSIS (OCCLUSION) WITH THE TRAILBLAZER AND A NON MEDTRONIC WIRE INSIDE THE TRAILBLAZER NO SUCCESS. THE PHYSICIAN DID NOT FEEL RESISTANCE WHILE MOVING BACK AND THE TIP SEPARATED AN IS NOW IN THE PATIENTS VESSEL. IT IS REPORTED THAT THE CURRENT SITUATION IS NOT LIFE THREATENING, THE VESSEL WAS OCCLUDED AND THE TRAILBLAZER CAN NOT MOVE TO THE DISTAL. PATIENT IS WAITING FOR A BYPASS OPERATION AND THE TIP OF THE TRAILBLAZER WILL BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651776 ↗
• InjuryAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING THE TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL REGION OF THE LEFT PERONEAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. NO RESISTANCE FELT WHEN ADVANCING THE DEVICE. IT WAS REPORTED DURING WITHDRAWAL RESISTANCE WAS FELT AND THE TIP EMBOLIZED. THE TIP TACKED INTO THE STENOSED LESION AFTER IT SNAPPED OFF WHEN ATTEMPTING TO WITHDRAW FROM THE VESSEL.

  Patient problems: Insufficient Information

  MAUDE report 17440805 ↗
• MalfunctionAug 4, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN USED A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF ATHEROSCLEROSIS OF THE PATIENT¿S LEFT LOWER EXTREMITY WITH GANGRENE OF THE LEFT GREAT TOE. DURING PROCEDURE, IT IS REPORTED THAT APPROXIMATELY 3CM OF THE CATHETER BROKE, AND THE DETACHED PORTION REMAINED IN THE PATIENT¿S LEFT ANTERIOR TIBIAL WHICH WAS VISUALIZED DURING ANGIOGRAM. NO INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10361223 ↗

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-