ENVOY 670-260-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704031796), received between Nov 5, 2024 and Feb 23, 2026 — classified as 2 malfunctions.

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

• MalfunctionFeb 23, 2026Contamination /Decontamination Problem; Physical Resistance/Sticking

  ON (B)(6) 2026, DURING AN EMBOLIZATION PROCEDURE TARGETING THE MIDDLE MENINGEAL ARTERY, UPON THE INSERTION OF THE 6F 90 CM, STRAIGHT ENVOY® GUIDING CATHETER (67026090 / 31740728), THERE WAS STRONG RESISTANCE BETWEEN THE ENVOY AND THE INNER CATHETER STARTING AROUND THE OPHTHALMIC ARTERY (AO). CONTINUOUS FLUSH WAS MAINTAINED. THE VESSEL COURSE WAS TORTUOUS. WHEN THE ENVOY WAS WITHDRAWN, AN UNIDENTIFIED MATERIAL WAS FOUND ATTACHED TO IT. THE ENVOY WAS REPLACED WITH A NEW ENVOY OF THE SAME SIZE, AND THE REPLACEMENT ENVOY CATHETER WAS USED WITH THE SAME INNER CATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 09-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION PROVIDED INCLUDES THE PHYSICIAN¿S COMMENTS ON THE REPORTED ISSUE AND DETAILS RELATED TO THE PROCEDURE. ¿THE AORTIC TORTUOSITY APPEARED TO HAVE SEVERAL MARKEDLY TORTUOUS SEGMENTS, WHICH I BELIEVE WAS ONE OF THE FACTORS CAUSING RESISTANCE DURING CATHETER INSERTION. THE TORTUOSITY AT THE [COMMON CAROTID ARTERY] CCA ORIGIN WAS SUCH THAT IT BENT ABOUT 90 DEGREES IMMEDIATELY AFTER ITS ORIGIN, AND I THOUGHT THIS WAS FAIRLY PRONOUNCED. THE INNER CATHETER U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415999 ↗
• MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE TARGETING AN ARTERIOVENOUS MALFORMATION (AVM), THE PHYSICIAN WAS GAINING ACCESS TO THE ARTERY WHILE ADVANCING A 6F 90 CM, STRAIGHT ENVOY® GUIDING CATHETER (67026090 / 31040775) WHEN IT WAS NOTICED THAT BLOOD WAS LEAKING AROUND THE HUB OF THE CATHETER WHERE THE YELLOW HUB MEETS THE WHITE ID BAND. THE ENVOY WAS REMOVED AND REPLACED WITH A NEW ONE AND THE PROCEDURE WENT FORWARD SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 04-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE AVM AND VESSEL CHARACTERISTICS (VESSEL TORTUOSITY OR ACUTE BENDS) ARE NOT KNOWN. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY (67026090).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613941 ↗