TrailBlazerRecalls & reported problems across all models

We found 13 models of TrailBlazer by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between May 18, 2017 and Mar 11, 2026 — classified as 37 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (54 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

Most reported TrailBlazer problems

TrailBlazer models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TrailBlazer™ SC-035-135

  Catheter, percutaneous
  20 reports
• TrailBlazer™ SC-018-150

  Catheter, percutaneous
  8 reports
• TrailBlazer™ SC-035-090

  CATHETER, PERCUTANEOUS
  7 reports
• TrailBlazer™ SC-018-135

  Catheter, percutaneous
  5 reports
• TrailBlazer™ SC-035-090

  Catheter, percutaneous
  4 reports
• TrailBlazer™ SC-018-135

  CATHETER, PERCUTANEOUS
  4 reports
• TrailBlazer™ SC-035-135

  CATHETER, PERCUTANEOUS
  4 reports
• TrailBlazer™ SC-014-150

  Catheter, percutaneous
  3 reports
• TrailBlazer™ SC-035-150

  Catheter, percutaneous
  3 reports
• TrailBlazer™ SC-018-150

  CATHETER, PERCUTANEOUS
  3 reports
• TrailBlazer™ SC-014-135

  Catheter, percutaneous
  2 reports
• TrailBlazer™ SC-018-090

  Catheter, percutaneous
  2 reports
• TrailBlazer™ SC-018-090

  CATHETER, PERCUTANEOUS
  2 reports

Recent TrailBlazer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE TRAILBLAZER SUPPORT CATHETER, A PATIENT UNDERWENT INTERVENTION FOR A TARGET LESION CHARACTERIZED BY SEVERE CALCIFICATION, 99% STENOSIS, 100MM LENGTH, AND 7MM DIAMETER, LOCATED IN THE MID LEFT COMMON ILIAC ARTERY. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTAL PORTION OF THE CATHETER DETACHED/FRACTURED AT THE TARGET LESION, RESULTING IN A 30-MINUTE DELAY IN SURGERY. THE DETACHED COMPONENT WAS REMOVED BY SNARING. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24568399 ↗
• 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 ↗
• MalfunctionMay 1, 2025Difficult to Advance; Material Deformation; Positioning Problem; Difficult to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PS SC-035-135 TRAILBLAZER, SEVERAL ISSUES WERE ENCOUNTERED. THE PATIENT'S ANATOMY EXHIBITED A SEVERE DEGREE OF TORTUOSITY, AND ABNORMALITIES WERE NOTED SPECIFICALLY WHEN CROSSING THE AORTA BIFURCATION. MODERATE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. THE DEVICE WAS UNABLE TO CROSS THE LESION. TRACKING DIFFICULTIES WERE ALSO NOTED DURING THE SECOND ADVANCEMENT DUE TO A TIGHT BIFURCATION AND THE PATIENT BEING VERY SMALL. IT WAS ALSO REPORTED THAT THE PHYSICIAN'S WIRE PUNCTURED THE TRAILBLAZER WHILE CROSSING THE BIFURCATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941157 ↗
• MalfunctionMar 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, THE PACKAGING LABEL FOR THE TRAILBLAZER SC-035-090 SUPPORT CATHETER DID NOT MATCH THE ACTUAL PRODUCT INSIDE, WHICH WAS A TRAILBLAZER SC-018-150 AND COULD NOT BE USED. DURING THE PROCEDURE, AFTER PLACING OVER NON-MEDTRONIC SHEATH AND USING A 0.035 NON-MEDTRONIC GUIDEWIRE TO OPEN THE LESION, IT WAS DISCOVERED THAT THE SUPPORT CATHETER UNPACKED WAS NOT AS LABELED. THE LOT NUMBER OF THE INNER PACKAGING AND THE LOT NUMBER OF THE OUTER PACKAGING WERE BOTH B797698. NO DAMAGE NOTED TO THE OUTER PACKAGING, THE STERILE PACKAGING WAS INTACT AND THE DEVICE WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED BY REPLACING THE INCORRECT CATHETER WITH A TRAILBLAZER SC-035-090 SUPPORT CATHETER, WHICH WAS THEN USED WITH A 35 SYSTEM GUIDEWIRE TO OPEN THE LESION AND INSERT A STENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547272 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE TRAILBLAZER SUPPORT CATHETER FOR PATIENT TREATMENT. THE PATIENT UNDERWENT LOWER EXTREMITY ARTERIAL STENT IMPLANTATION AND ANGIOGRAPHY UNDER MAC. DURING THE PROCEDURE THE SUPPORT CATHETER WAS USED TO PASS THE GUIDE WIRE, THE TIP OF THE SUPPORT CATHETER BROKE PASSING THROUGH THE GUIDEWIRE AND THE SURGERY COULD NOT BE CONTINUED. THE DEVICE WAS REPLACED WITH ANOTHER SUPPORT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206222 ↗
• MalfunctionNov 21, 2024Material Deformation; Material Deformation

  A TRAILBLAZER SUPPORT CATHETER WAS INTENDED TO BE USED DURING TREATMENT OF A LESION IN THE PROXIMAL REGION OF THE RIGHT COMMON ILIAC ARTERY. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY AND THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THERE WAS A HOLE IN THE MID PORTION OF THE CATHETER. THE GUIDEWIRE EXITED THE HOLE. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. ANOTHER TRAILBLAZER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742839 ↗
• InjuryJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A TRAILBLAZER SUPPORT CATHETER FOR TREATMENT OF A SOFT TISSUE LESION IN THE POSTERIOR TIBIAL ARTERY. THERE WAS NOT CALCIFICATION OR TORTUOSITY. THE IFU WAS FOLLOWED. IT WAS REPORTED A BALLOON DILATATION OPERATION WAS PERFORMED ON THE INFRAPOPLITEAL ARTERY. DURING THE OPERATION, IT WAS ADVANCED TO THE LOCATION OF THE ANTERIOR TIBIAL ARTERY LESION, A GUIDEWIRE WAS INSERTED, AND THE SUPPORT CATHETER WAS WITHDRAWN. DURING THE WITHDRAWAL PROCESS, THE CATHETER BROKE AND A PART OF IT REMAINED IN THE BLOOD VESSEL. THE SURGEON PUNCTURED AND WENT UPPER ON THE DORSALIS PEDIS ARTERY AND USED A CATCHER TO CATCH THE BROKEN PART AND REMOVED IT FROM THE BODY.

  Patient problems: Insufficient Information

  MAUDE report 19466045 ↗
• MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER WITH A 6FR NON-MEDTRONIC SHEATH AND AN 014 NON-MEDTRONIC GUIDEWIRE DURING PROCEDURE TO TREAT THE PATIENTS RIGHT AND LEFT SUPERFICIAL FEMORAL ARTERY (SFA). 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 DEVICE WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED A PORTION OF THE SHAFT DETACHED IN THE PATIENTS VESSEL. THE DETACHED PORTION WAS STUCK ON THE GUIDEWIRE AND REMOVED ONCE THE WIRE WAS PULLED OUT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220481 ↗
• 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 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A TRAILBLAZER TO TREAT A PLAQUE LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, TIBIAL/POPLITEAL TRUNK. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 40%. A 5FR 10CM TERUMO SHEATH WAS USED. A .035 ADVANTAGE WIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CATHETER BROKE OFF WHILE REMOVING IT FORM THE BODY. IT WAS STILL ATTACHED TO THE WIRE. IT DID NOT BREAK IN MULTIPLE SEGMENTS. ALL SEGMENTS/FRAGMENTS RETRIEVED. THE PHYSICIAN WAS ABLE TO PULL THE WIRE BACK TO RETRIEVE THE REST OF THE CATHETER TIP.  A 6FR 45CM DESTINATION SHEATH WAS PUT IN OVER THE ADVANTAGE WIRE AND BELOW THE KNEE WAS BALLOONED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579778 ↗
• 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 ↗
• InjuryOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING TREATMENT OF A CALCIFIED PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014 NON MEDTRONIC GUIDEWIRE WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED WHILE TRYING TO CROSS CTO SEVERAL TIMES BY TWISTING WIRE ENDED UP CORK SCREWING INSIDE THE TRAILBLAZER AND GETTING STUCK INSIDE OF IT. THE PHYSICIAN USED A LOT OF FORCE TO GET THE WIRE OUT OF TRAILBLAZER. UPON REMOVAL OF TRAILBLAZER AND WIRE THE PHYSICIAN NOTICED THAT 3 DOTS WERE STILL VISIBLE IN THE VESSEL. IT WAS DETERMINED THAT THE DISTAL END OF TRAILBLAZER BROKE OFF INTO THE VESSEL. THIS PIECE WAS SUCCESSFULLY REMOVED USING A SNARE. NO DAMAGE NOTED TO PATIENT. ONCE RETRIEVED THE PHYSICIAN ELECTED TO TERMINATE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919612 ↗
• 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 ↗

Other Ev3, Inc products

• EverCross114 models · 213 reports
• NanoCross Elite63 models · 206 reports
• SpiderFX8 models · 170 reports
• EverFlex Protégé EverFlex27 models · 94 reports
• Protégé GPS26 models · 39 reports · 1 recall
• NITREX11 models · 30 reports
• EverFlex14 models · 24 reports
• AMPLATZ GOOSE NECK10 models · 23 reports