ENROUTE Transcarotid Stent FG11815 (REF SR-080640-TCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00811311021277), received between Jul 23, 2024 and Sep 2, 2026 — classified as 1 death, 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Premature Activation

  Patient problems: Extravasation

  MAUDE report 50571956 ↗
• 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 2, 2026Positioning Problem

  IT WAS REPORTED THAT NO FLOW WAS OBSERVED FOLLOWING STENT DEPLOYMENT. THE PATIENT PRESENTED AS ASYMPTOMATIC FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID STENT (TSS) SYSTEM WAS SELECTED FOR USE. FOLLOWING STENT DEPLOYMENT AT THE LESION SITE, IMAGING DEMONSTRATED CONTRAST INFLOW INTO THE STENT WITH NO DISTAL OUTFLOW BEYOND THE STENT. AN ADDITIONAL ENROUTE STENT WAS PLACED, FOLLOWED BY DEPLOYMENT OF A THIRD ENROUTE STENT; HOWEVER, SUBSEQUENT IMAGING CONTINUED TO DEMONSTRATE ABSENCE OF DISTAL FLOW. A CUTDOWN WITH STENT EXPLANTATION WAS PERFORMED BY THE PHYSICIAN; HOWEVER, THE NUMBER OF STENTS REMOVED COULD NOT BE CONFIRMED. THE PHYSICIAN SUBSEQUENTLY PROCEEDED WITH CAROTID ENDARTERECTOMY (CEA). IMAGING CONTINUED TO DEMONSTRATE LACK OF FLOW TO THE BRAIN. THE PATIENT REQUIRED HOSPITALIZATION BEYOND THE STANDARD OF CARE. THE PATIENT OUTCOME WAS REPORTED AS EXPECTED TO FULLY RECOVER. UPON REVIEW OF THE PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY, THERE WAS CONCERN THAT THE TREATED LESION MAY HAVE REPRESENTED LONG-SEGMENT DISEASE. IT WAS FURTHER REPORTED THAT IT WAS UNCLEAR WHETHER THE STENTS WERE DEPLOYED WITHIN THE TRUE LUMEN OR FALSE LUMEN.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 25365610 ↗
• InjuryApr 22, 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 RIGHT SIDE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT EXHIBITED LABILE BLOOD PRESSURE DURING THE PROCEDURE, RANGING FROM 200MMHG TO BELOW 100MMHG. THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUES. TWENTY-EIGHT HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED LEFT SIDE WEAKNESS, SLURRED SPEECH AND FACIAL DROOP. IMAGING PERFORMED REVELED STENT THROMBOSIS. THE PATIENT IS SCHEDULED TO TRANSITION TO REHABILITATION.

  Patient problems: Dysphasia; Facial Paralysis; High Blood Pressure/ Hypertension; Ischemia Stroke; Low Blood Pressure/ Hypotension; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 24954770 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE, REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT EMERGED FROM GENERAL ENDOTRACHEAL ANESTHESIA (GETA) WITH LEFT SIDE FACE DROOP AND LEFT SIDE WEAKNESS THAT WAS WORSE THAN PRE-OPERATION BASELINE. IMAGING REVEALED AN OCCLUDED RIGHT COMMON CAROTID ARTERY AND RIGHT INTERNAL CAROTID ARTERY AND THROMBUS WITHIN THE STENT. A THROMBECTOMY WAS PERFORMED AND THE PHYSICIAN ELECTED TO RELINE THE STENT WITH AN ADDITIONAL ENROUTE STENT. THE PATIENT RETURNED TO BASELINE APPROXIMATELY FOUR HOURS POST THROMBECTOMY.

  Patient problems: Facial Paralysis; Muscle Weakness/Atrophy; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24185263 ↗
• DeathOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE, WHICH ULTIMATELY RESULTED IN DEATH. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. ONE HOUR POST PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS AND IMAGING PERFORMED REVEALED A HEMORRHAGIC STROKE. FURTHER IMAGE REVIEW REVEALED A LARGE RIGHT HEMISPHERE HEMORRHAGE WITH MIDLINE SHIFT, EDEMA, AND INTRAVENTRICULAR BLEEDING. ADDITIONALLY, IT WAS ALSO REPORTED THAT THE PATIENT HAD HIGH BLOOD PRESSURE BEFORE, DURING AND AFTER THE PROCEDURE. NO INTERVENTION WAS PERFORMED AND THE PATIENT PASSED AWAY ON (B)(6) 2025.

  Patient problems: Hemorrhagic Stroke; High Blood Pressure/ Hypertension

  MAUDE report 23302697 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE TCAR PROCEDURE, THE PATIENT HAD A SEIZURE WHILE ON CLAMP. THE PHYSICIAN DID NOT BELIEVE THE SEIZURE WAS DUE TO INTOLERANCE BUT RATHER CONSIDERED IT PART OF THE REPERFUSION SPECTRUM. THE PATIENT MADE A FULL RECOVERY, AND NO INTERVENTION WAS REQUIRED AS THE EVENT WAS SELF-LIMITING.

  Patient problems: Convulsion/Seizure

  MAUDE report 23032027 ↗
• InjuryAug 26, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT WOULD NOT EXPAND POST DEPLOYMENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE STENT WOULD NOT EXPAND POST DEPLOYMENT. POST-DILATION WAS ATTEMPTED AND DID NOT RESOLVE THE ISSUE. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893604 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND A HEMORRHAGIC STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TCAR PROCEDURE. THE PROCEDURE WAS PERFORMED ACCORDING TO PLAN WITH NO NOTABLE ISSUES. POST PROCEDURE, THE PATIENT WAS SHOWING SIGNS OF HYPOTENSION AND WAS TREATED FOR THAT. APPROXIMATELY 3-4 HOURS POST TCAR, THE PATIENT BEGAN TO EXPERIENCE STROKE SYMPTOMS. THE PATIENT WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT), WHICH REVEALED A SUBARACHNOID BLEED IN ADDITION TO WHAT WAS BELIEVED TO BE AN ACTIVE SUBCLAVIAN VEIN BLEED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM, WHERE IT WAS CONFIRMED THAT THE SUBCLAVIAN ARTERY WAS NOT THE SOURCE OF BLEEDING. INSTEAD, THE BLEEDING WAS LOCALIZED TO THE SURGICAL CUTDOWN SITE. THE SURGEON HAD MADE A SLIGHTLY LATERAL INCISION, WHICH MAY HAVE RESULTED IN AN INADVERTENT NICK TO THE SUBCLAVIAN VEIN DURING VASCULAR ACCESS. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS ON TRIPLE THERAPY; ELIQUIS (FOR PRE-EXISTING ATRIAL FIBRILLATION), ASPIRIN, AND CLOPIDOGREL, AND IT WAS SUGGESTED THAT ASPIRIN WAS THE MOST LIKELY CONTRIBUTOR TO THE BLEEDI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemorrhagic Stroke; Low Blood Pressure/ Hypotension

  MAUDE report 22731251 ↗
• MalfunctionJul 22, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS PLACED INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA) UNINTENTIONALLY. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE STENT WAS PLACED INTO THE RIGHT ICA UNINTENTIONALLY AND SUCCESSFULLY DEPLOYED PROPERLY. THERE WAS NO ISSUE REPORTED WITH THE STENT, NO REPORT OF AN ADVERSE EVENT, AND NO REPORTED INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564277 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED, WHICH WAS TREATED USING AN ADDITIONAL STENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER THE INITIAL TCAR PROCEDURE, THE PATIENT AWOKE AND WAS UNABLE TO MOVE HIS RIGHT ARM. THE SURGEON ELECTED TO RE-OPEN THE PATIENT AND PERFORM ANOTHER TCAR. HE BELIEVED THE STENTED PORTION NEEDED TO EXTEND INTO THE COMMON CAROTID ARTERY (CCA). THE SURGEON ACCESSED THE CCA AND REVIEWED THE EXTERNAL AND INTERNAL CAROTID ARTERIES ALONG WITH THE BRAIN FROM IMAGING. HE STATED EVERYTHING LOOKED GOOD, AND THERE WERE NO BLOCKAGES IN THE STENT OR THE CRANIAL VESSELS. HOWEVER, THE SURGEON DID SUSPECT THERE MIGHT BE A DISSECTION AT THE BIFURCATION OF THE CAROTID. A THIRD STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 22288595 ↗
• MalfunctionMar 3, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, POST SUCCESSFUL ENROUTE TRANSCAROTID STENT SYSTEM (TSS) STENT DEPLOYMENT, THE THIRD-PARTY (ABBOTT BMW) INTERVENTIONAL WIRE GOT STUCK ON THE STENT WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE WIRE BACK. IMAGING REVEALED THAT THE DEPLOYED STENT HAD MIGRATED DOWNWARD PARTIALLY IN THE COMMON CAROTID ARTERY (CCA) AND PARTIALLY AROUND THE TIP OF THE ARTERIAL SHEATH. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORMED A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506061 ↗
• InjuryJul 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY TWO HOURS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE. IMAGING WAS PERFORMED AND CONFIRMED THAT THERE WAS NO THROMBUS IDENTIFIED WITHIN THE STENT HOWEVER, THE STENT APPEARED TO NOT BE FULLY EXPANDED. THE PATIENT WAS ADMINISTERED THROMBOLYTICS AND NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT'S SYMPTOMS HAVE IMPROVED, BUT IT IS UNKNOWN IF THE SYMPTOMS HAVE COMPLETELY RESOLVED. ADDITIONAL INFORMATION RECEIVED ALSO INDICATED THAT THIS PATIENT HAD AN INTRALUMINAL CALCIUM BURDEN IN HIS RIGHT INTERNAL CAROTID ARTERY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke

  MAUDE report 19807524 ↗

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