ENVOY 671-258-95DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704075110), received between Feb 26, 2020 and Apr 20, 2026 — classified as 7 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.

• MalfunctionApr 20, 2026Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT WHILE PREPPING AN ENVOY DA XB, 6F, 95 CM CATHETER (PRODUCT CODE: 67125895DB, LOT NUMBER: 31618625), THERE WAS SMALL ¿FLAKING¿ AT TIP. IT APPEARED TO BE THE COATING. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926617 ↗
• MalfunctionMar 24, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A HUB DEFECT ON AN ENVOY DA XB, 6F, 95 CM, MPD (PRODUCT CODE: 67125895DB, LOT NUMBER: 31674324). THE WIRE COULD NOT BE INSERTED AND THE DEVICE WAS UNUSABLE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-MAR-2026 CONFIRMED THAT THE ¿HUB DEFECT¿ REFERRED TO A CRACK OR FRACTURE AT THE HUB. NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO FOLLOW-UP INTERVENTIONS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676554 ↗
• MalfunctionJul 24, 2025Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE HUB OF THE ENVOY DA XB, 6F, 95CM, MPD (67125895DB / 31502173) WAS BROKEN WHEN IT WAS FIRST OPENED. THE PHYSICIAN REPLACED IT WITH ANOTHER ENVOY DA XB, 6F, 95CM, MPD (67125895DB) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22599541 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THERE WAS A LEAK AT THE HUB OF THE ENVOY DA XB, 6F, 95CM, MPD (67125895DB / 31393518). MULTIPLE ROTATING HEMOSTASIS VALVES (RHVS) WERE TRIED IN ATTEMPT TO ALLEVIATE THE REPORTED LEAK, BUT THE CATHETER HUB KEPT LEAKING. THE LEAKING STOPPED WHEN THE PHYSICIAN REPLACED THE ENVOY CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. NO INTERVENTION WAS REQUIRED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 21-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS EMBOLIZATION OF MIDDLE MENINGEAL ARTERY (MMA) FOR SUBDURAL HEMATOMA (SDH). THE PROCEDURE WAS TARGETING THE COMMON CAROTID ARTERY. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY DA XB, 6F, 95CM, MPD (67125895DB).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075417 ↗
• MalfunctionApr 16, 2020Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE TIP OF A 6F, 95CM ENVOY DA XB CATHETER (67125895DB, LOT UNKNOWN) CRACKED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967435 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO AN ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM), AN ECLIPSE2L BALLOON WAS FIRST PLACED AND THEN A HEADWAY MICROCATHETER (MC) WAS USED AS USUAL. HOWEVER, THE MICROCATHETER DID NOT PASS THROUGH TWO 6F ENVOY DA 95 CM GUIDE CATHETERS (67125895DB, LOT UNKNOWN). IT SHOWED TO BE BROKEN FROM THE INSIDE AT THE HUBS, FROM THE OUTSIDE NO DEFECTS WERE DETECTABLE. THE DAMAGE SEEMINGLY AT THE END OF THE CATHETERS. BOTH COMPLETE SYSTEMS HAD TO BE REMOVED AND RE-LOADED. THERE WAS AN HOUR PROCEDURE DELAY DUE TO THE EVENT, HOWEVER, THE PATIENT DID NOT SUFFER ANY DAMAGE FROM THE PROLONGATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY THE USE OF A COMPETITOR¿S DEVICE. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICES. NO DEVICE FRAGMENTS REMAIN IN THE PATIENT. A PICTURE OF ONE DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758001 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO AN ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM), AN ECLIPSE2L BALLOON WAS FIRST PLACED AND THEN A HEADWAY MICROCATHETER (MC) WAS USED AS USUAL. HOWEVER, THE MICROCATHETER DID NOT PASS THROUGH TWO 6F ENVOY DA 95 CM GUIDE CATHETERS (67125895DB, LOT UNKNOWN). IT SHOWED TO BE BROKEN FROM THE INSIDE AT THE HUBS, FROM THE OUTSIDE NO DEFECTS WERE DETECTABLE. THE DAMAGE SEEMINGLY AT THE END OF THE CATHETERS. BOTH COMPLETE SYSTEMS HAD TO BE REMOVED AND RE-LOADED. THERE WAS AN HOUR PROCEDURE DELAY DUE TO THE EVENT, HOWEVER, THE PATIENT DID NOT SUFFER ANY DAMAGE FROM THE PROLONGATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY THE USE OF A COMPETITOR¿S DEVICE. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICES. NO DEVICE FRAGMENTS REMAIN IN THE PATIENT. A PICTURE OF ONE DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757943 ↗