ENROUTE Transcarotid Stent FG11815 (REF SR-100840-TCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811311021314), received between Sep 23, 2024 and Sep 22, 2026 — classified as 1 death, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE THE DAY FOLLOWING THE PROCEDURE. ADDITIONAL REPORTED COMPLICATIONS INCLUDED PARALYSIS AND EDEMA, INFLAMMATION, AND SWELLING. THE PATIENT PRESENTED AS SYMPTOMATIC FOR A LEFT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT SYSTEM (TSS) WAS SELECTED FOR USE. THE PATIENT REPORTEDLY PASSED THE POST-PROCEDURE NEUROLOGICAL CHECK; HOWEVER, THE FOLLOWING DAY, THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE WITH PARALYSIS AND EDEMA/INFLAMMATION/SWELLING. THE PATIENT WAS REPORTEDLY RESTARTED ON LOVENOX THE EVENING AFTER THE TCAR PROCEDURE. DUE TO THE SWELLING, THE PATIENT REPORTEDLY REQUIRED A CRANIOTOMY. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE PATIENT WAS BELIEVED TO BE ON TRIPLE THERAPY AND WAS HYPOTENSIVE POST-PROCEDURE, REQUIRING VASOPRESSOR SUPPORT. THE PATIENT WAS TRANSPORTED FROM RECOVERY TO THE NEURO INTENSIVE CARE UNIT, WHERE POSTOPERATIVE CARE WAS MANAGED. IT WAS SUSPECTED THAT STANDARD UNIT ORDER SETS MAY HAVE BEEN IMPLEMENTED, RESULTING IN THE PATIENT RECEIVING LOVENOX. THE EVENT WAS DESCRIBED AS A REPERFUSION EVENT.

  Patient problems: Cerebral Edema; Cerebral Hyperperfusion Syndrome; Hemorrhagic Stroke; Inflammation; Low Blood Pressure/ Hypotension; Paralysis; Reperfusion Injury

  MAUDE report 25340877 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WATERSHED STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, AFTER STENT PLACEMENT, THE NEUROMONITORING NOTED INTOLERANCE FLOW REVERSAL, THE PHYSICIAN SWITCHED TO LOW FLOW AND ULTIMATELY UNCLAMPED FOR ONE MINUTE. THE PHYSICIAN RE-CLAMPED AND COMPLETED THE PROCEDURE AND THE PATIENT WAS BACK TO BASELINE. THE NEXT DAY, EIGHTEEN HOURS POST PROCEDURE, THE PATIENT EXPERIENCED RIGHT LEG WEAKNESS UPON AMBULATION. IMAGING PERFORMED REVEALED PATENT STENT BUT CONFIRMED WATERSHED INFARCTS. THE PATIENT WILL BE GOING TO REHABILITATION WITH A GOOD PROGNOSIS FOR FULL RECOVERY.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 24222047 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE PROCEDURE, THE PATIENT HAD A STROKE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THE SYMPTOMS HAVE NOT BEEN RESOLVED YET. AT THIS TIME, THE ETIOLOGY OF THE STROKE AND WHETHER ANY INTERVENTION WAS PERFORMED ARE UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC.

  Patient problems: Stroke/CVA

  MAUDE report 23646297 ↗
• InjuryOct 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO BE REMOVED, RESULTING IN ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE STENT WAS SUCCESSFULLY DEPLOYED HOWEVER; THE PHYSICIAN WAS UNABLE TO REMOVE THE SDS. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE SDS, ATTEMPTED TO MANIPULATE THE NECK, AND ATTEMPTED TO ADVANCE A BUDDY WIRE TO REMOVE THE SDS, BUT TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND SURGICALLY EXPLANTED THE STENT. A PORTION OF THE ARTERY WAS REMOVED AND BYPASSED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AS A RESULT OF THE EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 23360585 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED BY THE PHYSICIAN THAT SOMETIME AFTER THE PROCEDURE, THE PATIENT HAD A STROKE. AT THIS TIME, IT IS UNKNOWN WHEN THE STROKE EVENT OCCURRED OR IF ANY INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 23058147 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A THROMBOTIC STROKE REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT PRESENTED AS ASYMPTOMATIC. FINAL ANGIOGRAMS WERE TAKEN IN ORTHOGONAL VIEWS, AND THE STENT WAS OBSERVED TO BE PATENT. THE PATIENT WOKE UP NEUROLOGICALLY INTACT. A FEW HOURS POST T-CAR, THE PHYSICIAN REPORTED THE PATIENT HAD STROKE-LIKE SYMPTOMS. A CTA OF THE HEAD AND NECK WAS PERFORMED, WHICH REVEALED THE STENT THROMBOSED NEAR THE BIFURCATION. THE PATIENT WAS STARTED ON INTEGRILIN AND HAD A THROMBECTOMY FOLLOWED BY PLACEMENT OF A WALLSTENT. THE PROCEDURE WAS SUCCESSFUL, AND THE STENT WAS PATENT. THE STROKE SYMPTOMS WERE REPORTED TO HAVE RESOLVED THE FOLLOWING DAY.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 22096001 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, UPON DISCHARGE, THE PATIENT EXPERIENCED RIGHT-SIDED UPPER EXTREMITY WEAKNESS AND APHASIA. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN OCCLUDED STENT, AND THE PHYSICIAN DETERMINED THE STROKE EVENT TO BE EMBOLIC. THE PHYSICIAN PERFORMED A MECHANICAL THROMBECTOMY AND PLACED AN UNPLANNED ADDITIONAL WALLSTENT. THE PATIENT WAS ADMINISTRATED A HEPARIN DRIP AND SYMPTOMS HAVE NOT RESOLVED YET. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT), AND A P2Y12 PLATELET FUNCTION TEST WAS NOT PERFORMED. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

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

  MAUDE report 20287779 ↗

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