ENROUTE Transcarotid Stent SR-0730-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811311020430), received between Aug 7, 2023 and Dec 2, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Defective Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P140026); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION WAS IDENTIFIED RESULTING IN AN ADDITIONAL STENT PLACEMENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE TCAR PROCEDURE, THE PHYSICIAN ADVANCED THE 0.014" GUIDEWIRE INTO THE INTERNAL CAROTID ARTERY (ICA), PRE-DILATED, PLACED AN ENROUTE STENT, AND POST-DILATED SUCCESSFULLY. IMAGING WAS THEN PERFORMED, AND IT REVEALED A DISSECTION JUST BEYOND THE DISTAL PORTION OF THE STENT IN THE ICA. THE PHYSICIAN ATTRIBUTED THE DISSECTION EVENT TO EITHER THE ENROUTE 0.014" GUIDEWIRE OR THE ENROUTE STENT AND ELECTED TO PLACE AN ADDITIONAL STENT TO COVER THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 23695022 ↗
• InjuryJul 2, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS INADVERTENTLY DEPLOYED A COLLATERAL VESSEL THAT CAME OFF THE ICA, REQUIRING ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE DISTAL PORTION OF THE STENT WAS INADVERTENTLY DEPLOYED IN A COLLATERAL VESSEL THAT CAME OFF THE INTERNAL CAROTID ARTERY (ICA) AND THE PROXIMAL PORTION OF THE STENT WAS DEPLOYED IN THE ICA. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA), EXPLANT THE STENT, AND USE A POLYTETRAFLUOROETHYLENE (PTFE) GRAFT INSTEAD OF A CAROTID PATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385659 ↗
• InjuryJun 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS 1 WEEK POST T-CAR, AND THE STENT APPEARED NARROWED. TWO ENROUTE TRANSCAROTID STENTS WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THERE WERE NO ISSUES WITH THE STENTS EXPANDING NOTED DURING THE PROCEDURE OR IN POST PROCEDURE IMAGING. ONE WEEK FOLLOWING THE TCAR PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH STROKE-LIKE SYMPTOMS. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY, AND THE PHYSICIAN HAD LIMITED ACCESS TO ADDITIONAL INFORMATION. THE PHYSICIAN WAS ABLE TO REPORT THAT ONE OF THE STENTS APPEARED NARROWED. NO FURTHER INFORMATION WAS AVAILABLE, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA

  MAUDE report 22159367 ↗
• InjuryMay 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS 1 WEEK POST TCAR, AND THE STENT APPEARED NARROWED. TWO ENROUTE TRANSCAROTID STENTS WERE SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THERE WERE NO ISSUES WITH THE STENTS EXPANDING NOTED DURING THE PROCEDURE OR IN POST PROCEDURE IMAGING. ONE WEEK FOLLOWING THE TCAR PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH STROKE-LIKE SYMPTOMS. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY, AND THE PHYSICIAN HAD LIMITED ACCESS TO ADDITIONAL INFORMATION. THE PHYSICIAN WAS ABLE TO REPORT THAT ONE OF THE STENTS APPEARED NARROWED. NO FURTHER INFORMATION WAS AVAILABLE, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA

  MAUDE report 22114138 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAPHOID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED BARORECEPTOR DYSFUNCTION. THE PATIENT REMAINED AN INPATIENT FOR THREE DAYS POST PROCEDURE AND WAS GIVEN NOREPINEPHRINE UNTIL THE BARORECEPTORS NORMALIZED. IT IS UNKNOWN IF THE ENROUTE TRANSCAPHOID STENT SYSTEM (TSS) CONTRIBUTED TO BARORECEPTOR DYSFUNCTION AND THEREFORE, THIS REPORT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19076246 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 9 DAYS AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED ACUTE STROKE WITH AN OCCLUDED STENT. THROMBECTOMY WAS PERFORMED TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S CONDITION HAD NOT YET RESOLVED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, NON-COMPLIANCE OR RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17873337 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD A STROKE WITH A LEFT-SIDED INFARCT. THE PHYSICIAN PERFORMED A THROMBECTOMY TO ADDRESS THE ISSUE. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE OR NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 17476382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140026. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2021 · Jan 13, 2021 · Terminated
  ENROUTE Transcarotid Stent System REF SR-XXYY-CS