ENROUTE Transcarotid Stent SR-0640-CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811311020416), received between Aug 16, 2019 and Feb 18, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A RIGHT TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2020. AN EXTRAVASATION OCCURRED AT THE MIDPORTION OF THE 6X40 ENROUTE STENT. THEREFORE, A 6X2.5 VIABHAN STENT WAS PLACED INSIDE OF THE ENROUTE STENT WHICH SUCCESSFULLY STOPPED THE LEAK. THE PHYSICIAN TOOK FINAL IMAGES AND EVERYTHING APPEARED FINE. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9724089 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BASELINED AT THE END OF THE PROCEDURE ON (B)(6) 2019. THE PHYSICIAN INFORMED A SILK ROAD MEDICAL PRINCIPAL THERAPY DEVELOPMENT SPECIALIST, THAT THE PATIENT SUFFERED A STROKE OVERNIGHT. THE PATIENT WAS SENT TO (B)(6) GENERAL HEALTH FOR NEURO RESCUE, AS BOTH STENTS HAD THROMBOSED. IT WAS ALSO OBSERVED THAT THERE WAS A SMALL DISSECTION AT THE SHEATH TIP DURING THE PROCEDURE. HOWEVER, THE PHYSICIAN INDICATED THAT IT DID NOT NEED TO BE TREATED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8903145 ↗

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