ENROUTE Transcarotid Stent FG11815 (REF SR-090730-TCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811311021284), received between Oct 2, 2024 and Nov 13, 2025 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ONE DAY AFTER THE PROCEDURE, THERE WAS SOME STENT COMPRESSION DUE TO CALCIUM AND THROMBUS WAS IDENTIFIED WITHIN THE STENT. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. PRIOR TO THE TCAR PROCEDURE, IT WAS IDENTIFIED THAT THE PATIENT'S ANATOMY HAD PINCH POINT CALCIUM. DESPITE THIS, THE TCAR PROCEDURE WENT WELL. POST PROCEDURE, THE PATIENT'S SYSTOLIC PRESSURES WERE LOWER, AROUND 100 MM HG, AND IMAGING REVEALED THROMBUS WITHIN THE STENT. ADDITIONALLY, THERE WAS SOME STENT COMPRESSION IDENTIFIED DUE TO CALCIUM WITH NO REPORT OF OCCLUSION OR INFLOW/OUTFLOW ISSUES. THE PHYSICIAN ELECTED TO SWITCH THE PATIENT TO BRILINTA AND CONTINUE WITH MEDICAL MANAGEMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 23547381 ↗
• DeathAug 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 BRAIN HEMORRHAGE, WHICH ULTIMATELY RESULTED IN DEATH. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT HAD A DILATED RIGHT EYE PUPIL AND WAS LETHARGIC. IMAGING REVEALED A BRAIN HEMORRHAGE. NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS PLACED ON COMFORT CARE AND ULTIMATELY PASSED AWAY.

  Patient problems: Eye Injury; Fatigue; Hemorrhagic Stroke

  MAUDE report 22913303 ↗
• InjuryOct 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR DAYS AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT HAD A STROKE WITH LEFT-SIDED WEAKNESS AND APHASIA. IMAGING REVEALED A RIGHT CENTRAL GYRUS INFARCT, AND THE STENT HAD 65% STENOSIS AS PER NORTH AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL (NASCET) CRITERIA. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT'S SYMPTOMS HAVE RESOLVED. 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: Dysphasia; Ischemia Stroke; Muscle Weakness/Atrophy; Stenosis

  MAUDE report 20353282 ↗

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