ENVOYRecalls & reported problems across all models

We found 5 models of ENVOY by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2017 and Sep 3, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Crack” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENVOY problems

ENVOY models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENVOY 671-258-05D

  CATHETER, PERCUTANEOUS
  25 reports
• ENVOY 671-258-95D

  CATHETER, PERCUTANEOUS
  18 reports
• ENVOY 671-258-05DB

  CATHETER, PERCUTANEOUS
  7 reports
• ENVOY 671-258-95DB

  CATHETER, PERCUTANEOUS
  7 reports
• ENVOY 671-256-05DB

  CATHETER, PERCUTANEOUS
  1 report

Recent ENVOY adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 11, 2026Physical Resistance/Sticking

  A healthcare professional reported that during the procedure, an ENVOY DA, 6F, 105CM, MPD Guide Catheter (product code: 67125805D, lot number: 31858974) was in place. A Micro-guidewire and microcatheter (both were other brands) were impeded in the middle section of the guide catheter and could not advance any more. The doctor removed the guide catheter, micro-guidewire and microcatheter from the patient together, then switched to a new guide catheter to complete surgery with the original micro-guidewire and microcatheter. There was no patient injury reported.Additional event information received on 31-Jul-2026 indicated that they were able to move the device. They were not able to torque the device. There was no evidence of physical material within the device. There was no difficulty removing the device from the patient. There was no procedure delayed/prolonged due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209540 ↗
• MalfunctionAug 11, 2026Physical Resistance/Sticking

  A healthcare professional reported that during a cerebral arteriovenous malformation embolization, an ENVOY DA, 6F, 105CM, MPD Guide Catheter (product code: 67125805D, lot number: 31892614) was in place and a competitor¿s microcatheter (MC) became impeded in the middle section of the guide catheter and could not advance any more. The doctor only retracted the microcatheter and switched to a second competitor¿s microcatheter. The second microcatheter had the same issue. The doctor removed the guide catheter and the second microcatheter from the patient together, then switched to a new guide catheter to complete surgery with the second microcatheter.Additional event information received on 31-Jul-2026 indicated that they were able to move the device. They were not able to torque the device. There was no evidence of physical material within the device. There was no difficulty removing the device from the patient. There was no procedure delayed/prolonged due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209277 ↗
• 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 ↗
• MalfunctionApr 23, 2026Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE ENVOY DA, 6F, 105CM, MPD (67125805D / 31434961) WAS DELIVERED IN PLACED AND THEN THE MICROCATHETER WAS DELIVERED IN THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE MIDDLE SECTION OF THE ENVOY GUIDE CATHETER AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN REMOVED THE GUIDE CATHETER AND MICROCATHETER FROM THE PATIENT AND REPLACED THE GUIDE CATHETER TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO. ON 15-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THE ASSOCIATED MICROCATHETER USED WAS A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE REPLACEMENT GUIDE CATHETER WAS ANOTHER ENVOY DA, 6F, 105CM, MPD (67125805D). THE INFORMATION CONFIRMED NO NEGATIVE IMPACT ON THE PATIENT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968356 ↗
• 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 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY, AFTER THE ENVOY DA, 6F, 105CM, MPD (67125805D / 31159024) WAS IN PLACE, BUBBLES WERE OBSERVED FROM THE TIP OF THE GUIDE CATHETER UNDER IMAGING. THE PHYSICIAN REMOVED THE ENVOY CATHETER AND FOUND THERE WAS A HOLE AT THE TIP OF THE ENVOY CATHETER. THE PHYSICIAN REPLACED THE ENVOY AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121345 ↗
• 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 ↗
• MalfunctionJul 14, 2025Peeled/Delaminated; Peeled/Delaminated

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE PROCEDURE, THE DOCTOR OPENED THE OUTER PACKAGING OF AN ENVOY DA, 6F, 105CM, MPD CATHETER (67125805D, LOT UNKNOWN) FOR INSPECTION AND OBSERVED THE COATING AT THE DISTAL END OF THE DEVICE HAD FALLEN OFF. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR CHANGED TO A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494667 ↗
• MalfunctionJul 14, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENVOY DA XB, 6F, 105CM, MPC GUIDE CATHETER (67125605DB, 31242284) WAS DELIVERED TO THE PATIENT. THE PROXIMAL END OF THIS GUIDE CATHETER WAS OBSERVED TO BE KINKED/BENT. THE DOCTOR REMOVED THE GUIDE CATHETER FROM THE PATIENT AND SWITCHED TO ANOTHER GUIDE CATHETER WITH THE SAME UNSPECIFIED MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUL-2025 INDICATED THAT THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN). THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494094 ↗
• MalfunctionJul 10, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENVOY DA, 6F, 105CM, MPD GUIDE CATHETER (67125805D, 31282758) WAS IMPEDED IN C1 SEGMENT OF CAROTID ARTERY AND COULD NOT DELIVER TO THE TARGET SITE. DOCTOR REMOVED THE GUIDE CATHETER FROM PATIENT AND FOUND THAT THE DISTAL END OF THE GUIDE CATHETER WAS KINKED/BENT. THE DOCTOR SWITCHED TO A NEW GUIDE CATHETER AND DELIVERED IT IN PLACE. THEN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31537084) WAS DELIVERED AND PLACED AND THEN AN UNSPECIFIED STENT WAS DELIVERED IN THE MICROCATHETER (MC). THE STENT WAS IMPEDED IN DISTAL END OF MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW MICROCATHETER TO DELIVER THE ORIGINAL STENT AND COMPLETED THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUL-2025 INDICATED THAT THE STENT WAS AN ENTERPRISE2 4MMX23MM (ENCR402312, LOT UNKNOWN). THERE WAS NO TORQUE DEVICE USED. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE MICROCATHETER WAS NOT KINK/BENT. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468858 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENVOY DA, 6F, 105CM, MPD CATHETER HUB (67125805D, LOT UNKNOWN) IS NOT WORKING TO REMOVE AIR INSIDE HUB. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411501 ↗
• MalfunctionMay 29, 2025Peeled/Delaminated; Peeled/Delaminated

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING FOR AN ENVOY DA, 6F, 105CM, MPD (67125805D / 31317942) FOR INSPECTION AND OBSERVED THAT THE INTRODUCER AND THE GUIDE CATHETER TIP WERE DEFORMED. THE DEVICE WAS NOT USED IN THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. ON 29-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE WAS FLUSHED AS THE PHOTO INCLUDED IN THE COMPLAINT SHOWS A SUBSTANCE COMING OUT OF THE CATHETER TIP. THERE WAS NO DELAMINATION NOTED. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PACKAGING BOX AND PACKAGING POUCH. THE SEAL HAS NOT BEEN COMPROMISED. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY DA, 6F, 105CM, MPD (67125805D).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106291 ↗
• 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 ↗

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