ENVOY 670-256-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704031697), received between Aug 8, 2024 and Feb 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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.

• MalfunctionFeb 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, BOTH ENVOY 6F, MPC 100CM CATHETERS (67025600, 31027256) HAD PROTRUDING PLASTIC RESIDUES FROM PRODUCTION ON THE THREADED PIECE. THE PROFESSOR DID NOT WANT TO USE THEM DUE TO THE RISK OF EMBOLIZATION. WE NOTICED THIS PROBLEM WHEN UNPACKING, SO THERE IS NO RISK OF INFECTION. NO PATIENT INJURY AS THE DEVICES WERE NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-FEB-2025 INDICATED THAT THE POUCHES WERE SEALED PRIOR TO BEING OPENED. THERE WAS NOT BEEN ANY PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364576 ↗
• MalfunctionFeb 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, BOTH ENVOY 6F, MPC 100CM CATHETERS (67025600, 31027256) HAD PROTRUDING PLASTIC RESIDUES FROM PRODUCTION ON THE THREADED PIECE. THE PROFESSOR DID NOT WANT TO USE THEM DUE TO THE RISK OF EMBOLIZATION. WE NOTICED THIS PROBLEM WHEN UNPACKING, SO THERE IS NO RISK OF INFECTION. NO PATIENT INJURY AS THE DEVICES WERE NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-FEB-2025 INDICATED THAT THE POUCHES WERE SEALED PRIOR TO BEING OPENED. THERE WAS NOT BEEN ANY PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364536 ↗
• MalfunctionAug 8, 2024Crack; Crack

  AS REPORTED BY THE FIELD, DURING TREATMENT OF AN INTERNAL CAROTID ARTERY STENOSIS WITH AN ENVOY 6F, MPC 100CM (67025600, 31258401) AND EMBOLIZATION. IN THE CASE OF THE ENVOY, THERE WAS A SPLINTER, WHICH IS WHY THE FILTER WIRE TWISTED. UNFORTUNATELY, THE FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM COULD NO LONGER BE USED AND HAD TO BE REPLACED. AFTER CHANGING THE ENVOY AND FILTER WIRE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A 10-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. BASED ON THE (B)(6) 2024 INDICATED THAT THE 10 MINUTES PROCEDURAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. IT WAS FURTHER CLARIFIED THAT THE REPORT OF ¿THERE WAS A SPLINTER¿ MEANS THAT THE CATHETER IS BROKEN. THERE WAS NO SEPARATION OF MATERIAL INTO 2 OR MORE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939510 ↗