ENVOY 670-252-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704031635), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 6F, 90 CM, SIMMONS 2 ENVOY® GUIDING CATHETER (67025290 / LOT# UNKNOWN) WAS USED IN A MECHANICAL THROMBECTOMY PROCEDURE. WHEN THE PHYSICIAN WAS TRYING TO GAIN ACCESS INTO THE LEFT INTERNAL CAROTID ARTERY (ICA), THE ENVOY CATHETER TWISTED TWICE IN THE VERY DIFFICULT ANATOMY AND WAS VERY HARD TO RETRIEVE. THE PHYSICIAN EXPLAINED THAT THE CATHETER ALMOST BECAME TORN DURING THE PULL BACK TO GET THE CATHETER OUT OF THE PATIENT. IT WAS REPORTED THAT THE ENVOY CATHETER WAS PULLED OUT AND WAS REPLACED WITH ANOTHER SMALLER DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; THERE WAS A DELAY, HOWEVER, THE DURATION WAS NOT REPORTED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388822 ↗