ENROUTE Transcarotid Stent FG11815 (REF SR-080630-TCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00811311021260), received between Sep 26, 2024 and May 11, 2026 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Positioning Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE NEXT MORNING THAT THE PATIENT HAD STROKE-LIKE SYMPTOMS. THE PATIENT WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN WHICH SHOWED THAT THE STENT WAS COMPRESSED PROXIMALLY AND APPEARED TO BE PLACED IN A DISSECTION PLANE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM, AND A CAROTID ENDARTERECTOMY (CEA) WAS PERFORMED WHERE THE STENT WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. AT THE TIME OF REPORTING, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY AND WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Stroke/CVA; Vascular Dissection

  MAUDE report 25140177 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION WAS IDENTIFIED REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, THE STENT WAS PLACED, POST DILATED, AND THEN AN ANGIOGRAM WAS PERFORMED. THE ANGIOGRAM REVEALED A PERFORATION IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND THE STENT WAS EXPLANTED.

  Patient problems: Perforation

  MAUDE report 24747182 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AFTER THE PATIENT WOKE UP FROM GENERAL ANESTHESIA, THE PATIENT MOVED ALL FOUR EXTREMITIES ON COMMAND. HOWEVER, WHILE THE PATIENT WAS IN THE OPERATING ROOM, ST DEPRESSION WAS NOTED ON THE MONITOR AND A 12-LEAD ELECTROCARDIOGRAM (EKG) INDICATED THAT THE PATIENT EXPERIENCED AN MI. THE PATIENT ALSO HAD ELEVATED TROPONIN LEVELS. A CARDIAC CATHETERIZATION WAS PERFORMED AS A RESULT OF THE EVENT, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 24461801 ↗
• InjuryJan 13, 2026Nonstandard Device

  IT WAS REPORTED THAT THE STENT WAS RECOILED, AND THE PATIENT EXPERIENCED ARM WEAKNESS. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED ARM WEAKNESS. IMAGING PERFORMED REVEALED THE STENT HAD RECOILED. THE NEXT MORNING, THE PATIENT SYMPTOMS WERE RESOLVED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR INTERVENTION. THE PHYSICIAN USED A BALLOON TO PRE-DILATE, PLACED A SECOND STENT OVER THE INITIAL STENT, AND POST-DILATED WITH BALLOON. THE STENT EXPANDED WELL, AND THE PATIENT WOKE UP NEUROLOGICALLY INTACT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 24061425 ↗
• DeathSep 25, 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. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE TCAR PROCEDURE, THE PATIENT'S BLOOD PRESSURE WAS WITHIN RANGE PER THE INSTRUCTION FOR USE HOWEVER, THE PATIENTS BLOOD PRESSURE SPIKED SIGNIFICANTLY DURING INDUCTION OF GENERAL ANESTHESIA AND AT THE TIME OF CAROTID CUT DOWN. AFTER THE PROCEDURE, THE PATIENTS BLOOD PRESSURE REMAINED HIGH, AND THEY WERE UNABLE TO BE EXTUBATED. THE PHYSICIAN ELECTED TO RE-ENTER THE VESSEL THROUGH THE GROIN TO EVALUATE THE STENT WHICH WAS PATENT AND IMAGING REVEALED A HEMORRHAGIC STROKE. NO INTERVENTION WAS PERFORMED AND THE PATIENT DIED ON (B)(6) 2025.

  Patient problems: Hemorrhagic Stroke; High Blood Pressure/ Hypertension

  MAUDE report 23149836 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX HOURS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED LEFT SIDED WEAKNESS. IMAGING REVEALED SMALL EMBOLISMS ON THE RIGHT SIDE AND THROMBUS WAS IDENTIFIED IN THE DISTAL PORTION OF THE STENT. THE PATIENT WAS IN REHABILITATION AND WAS DISCHARGED ON (B)(6) 2024 WITH NO RESIDUAL DEFICITS. 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, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

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

  MAUDE report 20312436 ↗

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