ENVOY 670-258-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704031758), received between Apr 22, 2020 and Dec 29, 2022 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF A PROCEDURE, A ¿BLACK DEPOSIT¿ WAS NOTED UPON THE OPENING OF THE COMPLAINT DEVICE, AN ENVOY® GUIDING CATHETER 6F, 90 CM, MPD (67025890 / 30769441). THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT / NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075704 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY. THE 80-YEAR-OLD FEMALE SUBJECT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), DIABETES, HYPERTENSION, LIVER DISEASE AND PREVIOUSLY SMOKING, UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL SUBDURAL HEMATOMA (SDH) ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL MEDICAL MANAGEMENT (NSMM) AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE SDH THICKNESS WAS 23. THE MMA EMBOLIZATION PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA RIGHT RADIAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (631500 / LOT # JN8395); (4:1 OIL: N-BCA RATIO) WAS DELIVERED BEYOND THE MIDLINE VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A 6F, 90CM MPD ENVOY® GUIDING CATHETER (67025890 / 67025890) WAS USED DURING THE PROCEDURE. THE ANTERIOR BRANCH OF THE MMA WAS EMBOLIZED. DURING THE PROCEDURE THE PATIENT EXPERIENCED VASOSPASM OF THE EXTERNAL CAROTID ARTERY (ECA) FOR APPROXIMATELY 14 MINUTES. THIS EVENT WAS TREATED MEDICALLY. IN THE OPINION OF THE TREATING PHYSICIAN THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED

  Patient problems: Vasoconstriction

  MAUDE report 15746903 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, A (B)(6) MALE ((B)(6)) WITH A HISTORY OF HEAD INJURY WITHIN THE LAST 12 MONTHS, CONTROLLED HYPERTENSION, AND TRANSIENT ISCHEMIC ATTACK (TIA) UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT PARIETAL SUBDURAL HEMATOMA (SDH) ON (B)(6) 2021 AND EXPERIENCED MODERATE SDH REOCCURRENCE ON (B)(6) 2021. THE THICKNESS OF THE SDH WAS 22MM. THE EVENT REQUIRED MEDICAL INTERVENTION, REOPERATION (I.E., CRANIOTOMY), AND IN-PATIENT HOSPITALIZATION. THE PATIENT IS RECOVERING FROM THE EVENT. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS SERIOUS AND NOT RELATED TO THE STUDY DEVICE, STUDY MMA EMBOLIZATION, OR SURGICAL PROCEDURE. THE PATIENT WAS RANDOMIZED INTO THE SURGERY AND MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 3. THE SDH THICKNESS WAS 13MM. BURR HOLE SURGERY (TWO HOLES) WAS PERFORMED ON (B)(6) 2021. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2021 VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (631500/JH1680) (3.5:1 OIL: N-BCA RATIO) WAS DELIVERED VIA A ECHELON 10 MICROCATHETER (MEDTRONIC). PER THE INFORMATION ENTERED ON THE

  Patient problems: Vasoconstriction

  MAUDE report 12736862 ↗
• MalfunctionApr 22, 2020Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE TIP OF A 90CM 6F ENVOY CATHETER (67025890, 30157371) CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986121 ↗