ENVOY 670-256-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704031710), received between Feb 28, 2018 and Oct 30, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 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.

• MalfunctionOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE DIAGNOSTIC ANGIOGRAM PROCEDURE, THE ENVOY® GUIDING CATHETER, 6F, 90 CM, MPC LEAKED DIAGNOSTIC CONTRAST. THE REPORTED LEAK WAS NOTED WHEN THE CATHETER WAS BEING FLUSHED. THE LEAK WAS DISCOVERED PRIOR TO THE CATHETER BEING INSERTED INTO THE PATIENT. IT WAS REPORTED THAT THE LOCATION OF THE LEAK WAS AT THE WELD JUNCTION BETWEEN THE PROXIMAL BLUE AND DISTAL YELLOW POLYMER SEGMENT OF THE CATHETER. THE ENVOY GUIDING CATHETER DID NOT APPEAR DAMAGED PRIOR TO THE LEAK BEING NOTICED; NO EXCESSIVE FORCE WAS APPLIED. ANOTHER ENVOY GUIDING CATHETER WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PROCEDURAL DELAY, NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020157 ↗
• MalfunctionFeb 28, 2018Material Frayed; Material Frayed

  THE HEALTH CARE PROFESSIONAL REPORTED THAT THE ENVOY 6F, MPC 90CM GUIDING CATHETER (67025690 / 17707474) DID NOT FIT INTO THE CORDIS 6F SHORT SHEATH. THE DEVICE WAS EXAMINED AND IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDING CATHETER APPEARED A LITTLE FRAYED, THE NOTED ISSUE IS NOT CONDUCIVE TO SMOOTH ACCESS. A NEW ENVOY 6F, MPC 90CM GUIDING CATHETER WAS USED AND THE NEW GUIDING CATHETER WAS REPORTED TO FITTED WELL. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304546 ↗