ENROUTE Transcarotid StentRecalls & reported problems across all models

We found 14 models of ENROUTE Transcarotid Stent by Silk Road Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 303 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Sep 24, 2026 — classified as 19 deaths, 261 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

ENROUTE Transcarotid Stent recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 13, 2021Terminated

   Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

   Z-1146-2021 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

Most reported ENROUTE Transcarotid Stent problems

ENROUTE Transcarotid Stent models

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

• ENROUTE Transcarotid Stent SR-0940-CS

  Stent, Carotid
  1 recall5 deaths58 reports
• ENROUTE Transcarotid Stent SR-1040-CS

  Stent, Carotid
  1 recall3 deaths56 reports
• ENROUTE Transcarotid Stent SR-0930-CS

  Stent, Carotid
  1 recall1 death21 reports
• ENROUTE Transcarotid Stent SR-1030-CS

  Stent, Carotid
  1 recall2 deaths15 reports
• ENROUTE Transcarotid Stent SR-0840-CS

  Stent, Carotid
  2 deaths60 reports
• ENROUTE Transcarotid Stent SR-0830-CS

  Stent, Carotid
  22 reports
• ENROUTE Transcarotid Stent FG11815

  Stent, Carotid
  2 deaths17 reports
• ENROUTE Transcarotid Stent SR-0740-CS

  Stent, Carotid
  13 reports
• ENROUTE Transcarotid Stent FG11815

  Stent, Carotid
  1 death13 reports
• ENROUTE Transcarotid Stent FG11815

  Stent, Carotid
  1 death10 reports
• ENROUTE Transcarotid Stent SR-0730-CS

  Stent, Carotid
  7 reports
• ENROUTE Transcarotid Stent FG11815

  Stent, Carotid
  1 death6 reports
• ENROUTE Transcarotid Stent FG11815

  Stent, Carotid
  1 death3 reports
• ENROUTE Transcarotid Stent SR-0640-CS

  Stent, Carotid
  2 reports

Recent ENROUTE Transcarotid Stent adverse event reports

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

• MalfunctionSep 24, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891902 ↗
• MalfunctionSep 22, 2026Nonstandard Device; Difficult to Remove; Difficult or Delayed Activation

  It was reported that the stent was difficult to deploy. The delivery system also experienced difficulty during removal and exhibited damage.The patient presented as asymptomatic for a right Transcarotid Artery Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent (TSS) System was selected for use. It was reported that the stent was difficult to deploy. Following stent deployment, resistance was encountered during removal of the delivery system. Upon removal, the physician observed that the metal had uncoiled on the delivery system. The procedure was completed, and the patient was reported as stable. No abnormal patient anatomy or lesion was identified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859318 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 50765895 ↗
• DeathSep 10, 2026Use of Device Problem; Positioning Problem

  It was reported that the patient developed an occlusion secondary to a dissection, requiring additional intervention. The patient subsequently suffered a stroke and later died.The patient presented as symptomatic for a left Transcarotid Artery Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent System (TSS) was selected for use. Following the procedure, imaging reportedly demonstrated sluggish flow toward the distal circulation; however, the flow was determined as acceptable, and the patient was closed. The patient later became symptomatic, and computed tomography angiography (CTA) identified occlusion of the left internal carotid artery (ICA) at the petrous and cavernous segments. A thrombectomy was performed but did not improve the patient's symptoms. Subsequently, stent removal and carotid endarterectomy (CEA) were performed. A repeat CTA reportedly demonstrated ICA dissection and a non-occlusive stroke, after which the patient was placed on comfort care. A subsequent CTA reportedly showed ischemic changes in the left frontal lobe. The patient later died, and the official cause of death not provided.Further review of the CTA images dated (b)(6) 2026 identified cont

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 50703260 ↗
• DeathSep 10, 2026Use of Device Problem; Positioning Problem

  It was reported that the patient developed an occlusion secondary to a dissection, requiring additional intervention. The patient subsequently suffered a stroke and later died.The patient presented as symptomatic for a left Transcarotid Artery Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent System (TSS) was selected for use. Following the procedure, imaging reportedly demonstrated sluggish flow toward the distal circulation; however, the flow was determined as acceptable, and the patient was closed. The patient later became symptomatic, and computed tomography angiography (CTA) identified occlusion of the left internal carotid artery (ICA) at the petrous and cavernous segments. A thrombectomy was performed but did not improve the patient's symptoms. Subsequently, stent removal and carotid endarterectomy (CEA) were performed. A repeat CTA reportedly demonstrated ICA dissection and a non-occlusive stroke, after which the patient was placed on comfort care. A subsequent CTA reportedly showed ischemic changes in the left frontal lobe. The patient later died, and the official cause of death not provided.Further review of the CTA images dated (b)(6)2026 identified contr

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 50703259 ↗
• InjurySep 9, 2026Fracture

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 50702619 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient did not move their left side and imaging revealed a brain bleed. An ENROUTE Transcarotid Stent was selected for use in a right sided Transcarotid Artery Revascularization (TCAR) procedure. The patient had multiple risk factors including a high lesion however, the procedure was completed as planned and the stent looked great. During extubation, patient did not move their left side, and the Computed Tomography Angiography (CTA) imaging revealed a brain bleed. Additionally, it was reported that the patient experienced Cerebral Hyperfusion Syndrome. The physician stated that the neurosurgeon reported the patient was "unsurvivable."

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke

  MAUDE report 50679512 ↗
• InjurySep 2, 2026Premature Activation

  Patient problems: Extravasation

  MAUDE report 50571956 ↗
• DeathAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a stroke and the patient passed away.An ENROUTE Transcarotid Stent was selected for use in a right sided Transcarotid Artery Revascularization (TCAR) procedure. After the TCAR procedure, the patient experienced a hemorrhage stroke with left sided deficit after extiubation. The physician reported that the patient did not have high-risk features for cerebral hyperperfusion syndrome. It was further reported that the patient passed away.

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke; Muscle Weakness/Atrophy

  MAUDE report 50124309 ↗
• DeathJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a hemorrhagic stroke. The patient also expired.The patient presented as asymptomatic for a right Transcarotid Revascularization (TCAR) procedure. An ENROUTE Transcarotid Stent (TSS) System was selected for use. Prior to discharge, the patient experienced a hemorrhagic stroke. The patient subsequently died. The official cause of death was reported as hemorrhage.

  Patient problems: Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke

  MAUDE report 50092674 ↗
• InjuryJul 10, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS NOTED THAT THE PATIENT'S INTERNAL CAROTID ARTERY (ICA) HAD A HEAVY CALCIUM BURDEN AND THE PHYSICIAN ELECTED TO USE A NON-BSC DEVICE TO PREDILATE THE VESSEL. AFTER THE STENT WAS PLACED, THE PHYSICIAN DECIDED IT LOOKED GOOD IN THE ANGIOGRAM AND ELECTED TO NOT POST DILATE. FOUR HOURS POST TCAR PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND A STROKE WITH RIGHT EYE VISION CHANGES, LEFT FACIAL DROOP, AND SPEECH ISSUES. ADDITIONALLY, THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED SIGNIFICANT CALCIFIC BURDEN IMPACTING THE VESSEL AND STENT, WITH EVIDENCE THAT THE STENT WAS COMPRESSED AND SUBSEQUENTLY THROMBOSED, RESULTING IN FULL OCCLUSION. THE ICA APPEARED SEVERELY COMPROMISED WITH MINIMAL FLOW AT THE SKULL BASE. THE PATIENT WAS FLOWN TO A DIFFERENT HOSPITAL AND THE STENT WAS EXPLANTED. THE PATIENT'S SYMPTOMS RESOLVED WITHIN 24 HOURS AFTER THE STENT WAS EXPLANTED.

  Patient problems: Blurred Vision; Facial Paralysis; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Speech Disorder; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25786571 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT THROMBOSIS. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST PROCEDURE, THE PATIENT INITIALLY AWOKE AGITATED BUT WAS ABLE TO FOLLOW COMMANDS. FEW HOURS LATER, SHE BECAME UNRESPONSIVE WHILE IN THE POST-ANESTHESIA CARE UNIT (PACU). SUBSEQUENT IMAGING REVEALED THROMBOSIS WITH MINIMAL TO NO FLOW DISTAL TO THE STENT. THE PHYSICIAN ALSO REPORTED THAT THE PATIENT EXPERIENCED A MIDDLE CEREBRAL ARTERY (MCA) STROKE. A CAROTID ENDARTERECTOMY (CEA) WAS PERFORMED AND THE STENT WAS EXPLANTED.

  Patient problems: Loss of consciousness; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25751125 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND THROMBOSIS WAS IDENTIFIED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN ACUTE ISCHEMIC STROKE (AIS) THROMBECTOMY.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 25550595 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBUS WAS IDENTIFIED WITHIN THE STENT AND THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT PASSED THE NEUROLOGICAL CHECK AND WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT (PACU). APPROXIMATELY THIRTY MINUTES LATER, THE PATIENT WAS NO LONGER MOVING RIGHT ARM AND LEG. IMAGING REVEALED NO FLOW THROUGH THE STENT AND THROMBUS IN THE STENT. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND SHUNT WAS PLACED. THE PATIENT WOKE UP IN THE OPERATING ROOM AND WAS STILL UNABLE TO MOVE THEIR RIGHT ARM OR LEG. FURTHER UPDATES TO THE PATIENT STATUS WERE NOT PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 25538382 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST-PROCEDURE, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED LEFT LEG DEFICIT, AND IMAGING REVEALED AN ISCHEMIC STROKE WITH ANTERIOR CEREBRAL ARTERY (ACA) DISEASE. THE STENT WAS PATENT. NO INTERVENTION WAS PERFORMED, AND THE PATIENT DEMONSTRATED IMPROVING STRENGTH WITH APPROXIMATELY 50% OVERALL IMPROVEMENT. ADDITIONALLY, IT WAS REPORTED THAT THIS PATIENT DEMONSTRATED EXTENSIVE LOW-DENSITY PLAQUE, DESCRIBED AS FRIABLE MATERIAL WITH HOUNSFIELD UNIT VALUES LESS THAN 50, INCLUDING AREAS AS LOW AS 16. LIMITED VISUALIZATION OF THE A2 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY WAS ALSO NOTED.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 25498613 ↗

Other Silk Road Medical, Inc. products

• ENROUTE Transcarotid Neuroprotection System2 models · 706 reports · 1 recall
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