ENVOY 671-258-05DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704075097), received between Dec 23, 2019 and Sep 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591430 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENVOY DA XB, 6F, 105CM, MPD (67125805DB/ 31636447) WAS USED FOR A BALLOON-ASSISTED COILING PROCEDURE FOR A PATIENT WITH SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6) 2025. THE EVENT WAS REPORTED AS SUCH, ¿PATIENT ON (B)(6) 2025 (FALL1). SAH BALLOON-ASSISTED COILING. ENVOY DA, ECLIPSE, SL 10, FLARE CHANGES. STATUS EPILEPSY. RHEUMATOLOGICAL DIAGNOSTICS NONSPECIFIC. AUTOIMMUNE MARKER.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 21-APR-2026. SUMMARY: A USER REPORT FROM BFARM- FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES - WAS RECEIVED ON 21-APR-2026. THE USER REPORT REFERENCES TWO SEPARATE COMPLAINTS¿(B)(4); ALL THREE COMPLAINTS WERE RECEIVED CONCURRENTLY FROM THE SAME REPORTING SOURCE AND ARE CONSIDERED PART OF A RELATED EVENT SET. IN TWO OF THE THREE CASES, THE TREATING PHYSICIAN EXPLICITLY RAISED SUSPICION OF DEVICE COATING SHEDDING AS A POTENTIAL ETIOLOGY (AS STATED IN THE USER REPORT). GIVEN THE SHARED CONTEXT AND TIMING, THIS COMPLAINT IS BEING REASSESSED UNDER THE SAME POTENTIAL MECHANISM, INCLUDING A POSSIBLE FOREIGN BODY REACTION, TO ENSURE A CONSISTENT AND A CONSERVATIVE ASSESSMENT. REVIEW OF MRI IMAGE HEADERS YIELDED ADDITIONA

  Patient problems: Convulsion/Seizure; Foreign Body Reaction; Ischemia; Unspecified Nervous System Problem

  MAUDE report 25115597 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ENVOY DA XB, 6F, 105CM, MPD (67125805DB / LOT# UNKNOWN) WAS BROKEN INSIDE THE VESSEL DURING A PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735975 ↗
• MalfunctionMar 21, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 6F, 105CM ENVOY DA XB GUIDE CATHETER (67125805DB / 31098099) WAS IN PLACE AND THE MICROCATHETER (COMPETITOR BRAND) WAS DELIVERED INTO THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE GUIDE CATHETER AND COULD NOT PASS THROUGH. THE PHYSICIAN REMOVED THE GUIDE CATHETER AND THE MICROCATHETER FROM THE PATIENT. IT WAS REPORTED THAT THE ENVOY GUIDE CATHETER WAS OBSERVED TO BE KINKED. THE PHYSICIAN REPLACED THE DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO WAS INCLUDED IN THE COMPLAINT. ON 05-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE TARGET WAS THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). IT WAS CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 05-MAR-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956627 ↗
• MalfunctionMar 2, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF THE 105CM, 6F MPD ENVOY DA XB (67125805DB / E12072) WAS CRACKED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775656 ↗
• MalfunctionFeb 19, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF THE 105CM, 6F MPD ENVOY DA XB (67125805DB / E11885) WAS CRACKED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728183 ↗
• MalfunctionDec 23, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE ENVOY DA XB, 6F, 105CM (67125805DB / E11907) WAS SNAPPED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511465 ↗