ENVOY 670-258-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704031734), received between Dec 17, 2018 and Jun 16, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN ENVOY 6F, MPD 100CM GUIDE CATHETER (PRODUCT CODE: 67025800, LOT NUMBER: 31312323) WAS DELIVERED IN PLACE AND THEN AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED IN THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE DISTAL END OF THE GUIDE CATHETER AND COULD NOT PASS THROUGH THE GUIDE CATHETER. THE DOCTOR REMOVED THE GUIDE CATHETER AND MICROCATHETER FROM THE PATIENT, THE GUIDE CATHETER TIP WAS FOUND KINKED/BENT. THE DOCTOR SWITCHED TO A NEW GUIDE CATHETER TO COMPLETE SURGERY WITH THE ORIGINAL MICROCATHETER. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. PRIOR TO THE PROCEDURE, THE DEVICE OUTER PACKAGING AND THE DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-JUN-2026 INDICATED THAT THERE WAS FLUSHING DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT, HOWEVER, IT DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523430 ↗
• MalfunctionJan 20, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AN ENVOY 6F, MPD 100CM (PRODUCT CODE 67025800, LOT NUMBER 31438233) BECOME OBSTRUCTED AND KINKED/BENT. DURING THE PROCEDURE, THE GUIDE CATHETER WAS DELIVERED IN PLACE, FOLLOWED BY THE UNSPECIFIED MICROCATHETER (MC). THE MICROCATHETER WAS IMPEDED AT THE DISTAL END OF THE GUIDE CATHETER AND COULD NOT PASS THROUGH. BOTH THE GUIDE CATHETER AND MICROCATHETER WERE REMOVED, AND THE DISTAL TIP OF THE GUIDE CATHETER WAS OBSERVED TO BE KINKED OR BENT. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE CATHETER FROM ANOTHER BRAND WITH THE ORIGINAL MICROCATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT. THE DEVICE'S OUTER PACKAGING AND THE DEVICE ITSELF WERE INSPECTED PRIOR TO USE AND FOUND TO BE IN GOOD CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116813 ↗
• MalfunctionJun 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY, AN ENVOY® GUIDING CATHETER, 6F, 100 CM, MPD (67025800 / 31312321) WAS DELIVERED IN PLACE AND THEN THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) WAS DELIVERED IN THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE MIDDLE SECTION OF THE GUIDE CATHETER BUT IT STILL PASSED THROUGH THE GUIDE CATHETER AND WAS DELIVERED TO THE TARGET. LATER IN THE PROCEDURE, THE 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE (ENCR402300 / 9368822) WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH IT. THE PHYSICIAN REMOVED ALL THREE DEVICES FROM THE PATIENT AND REPLACED THE GUIDE CATHETER AND THE STENT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 16-JUN-2025, IT WAS INDICATED THAT ADDITIONAL INFORMATION CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237673 ↗
• MalfunctionApr 9, 2024Crack; Crack

  AS REPORTED VIA THE HEALTH AUTHORITY REPORT, THE ENVOY® GUIDING CATHETER, 6F, 100 CM, MPD (67025800 / 30914085) WAS INSERTED, IT WAS OBSERVED FRACTURED / CRACKED AND THE GUIDE WIRE COULD NOT BE DELIVERED TO THE TARGET SITE. THE ENVOY CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 08-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS MEDIAN CEREBRAL IMAGING. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY® GUIDING CATHETER, 6F, 100 CM, MPD (67025800) THE SAME GUIDEWIRE WAS USED AFTER THE GUIDE CATHETER WAS REPLACED. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076709 ↗
• MalfunctionDec 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, THE NURSE NOTICED A ¿BLACK DOT¿ ON THE SURFACE OF AN ENVOY 6F, MPD 100CM CATHETER (67025800, LOT UNKNOW). NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310236 ↗
• InjuryOct 31, 2023Material Twisted/Bent; Material Twisted/Bent

  THE EVENT WAS REPORTED VIA A HEALTH AUTHORITY REPORT; THE 68-YEAR-OLD MALE PATIENT WITH A CEREBRAL INFARCTION UNDERWENT A THROMBECTOMY PROCEDURE. AN ENVOY® GUIDING CATHETER, 6F, 100 CM, MPD (67025800 / 30717738) WAS USED TO ENTER BLOOD VESSEL AFTER A SUCCESSFUL PUNCTURE. THE ENVOY GUIDING CATHETER WAS FOUND TO BE KINKED / BENT DURING THE PROCESS OF ENTERING THE BLOOD VESSEL, WHICH RESULTED IN POOR SURGICAL CHANNEL AND DELAYED VASCULAR PATENCY AND BRAIN CELLS COULD NOT RECEIVE TIMELY BLOOD SUPPLY. A NEW GUIDE CATHETER WAS IMMEDIATELY USED AS REPLACEMENT TO CONTINUE WITH THE PROCEDURE. ON 26-OCT-2023, IT WAS INDICATED THAT ADDITIONAL INFORMATION RELATED TO THE EVENT, THE PROCEDURE AND THE REPORTED DEVICE ISSUE CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18042913 ↗
• MalfunctionSep 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED A PATIENT PRESENTING WITH AN ANTERIOR CEREBRAL ARTERY ANEURYSM UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE GUIDE CATHETER, AN ENVOY® GUIDING CATHETER, 6F, 100 CM, MPD (67025800 / 30824156) WAS PLACED AT THE TARGET SITE, THEN A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31000498) WAS DELIVERED INTO THE GUIDE CATHETER. IT WAS REPORTED THAT WHEN THE MICROCATHETER WAS ADVANCING AT THE DISTAL END OF THE GUIDE CATHETER, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE. A 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 7258214) WAS IMPEDED AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH. THE PHYSICIAN REMOVED THE GUIDE CATHETER, THE MICROCATHETER, AND THE STENT FROM THE PATIENT¿S ANATOMY AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715696 ↗
• MalfunctionAug 28, 2023Material Separation; Material Separation

  AS REPORTED BY THE HEALTH AUTHORITY, THE PHYSICIAN OPENED THE PACKAGING OF AN ENVOY 6F, MPD 100CM GUIDE CATHETER (67025800, 30759475) AND OBSERVED THAT THE GUIDE CATHETER WAS SEPARATED. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632947 ↗
• MalfunctionJul 27, 2022Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, A 6F ENVOY GUIDE CATHETER, MPD 100CM (67025800, 30540615) KINKED DURING THE INTERVENTION CASE. THEREFORE, THE PHYSICIAN CHANGED ANOTHER PRODUCT, AND THE PROCEDURE DONE WELL. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, A FRACTURE WAS NOTED ON THE BRITE TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113249 ↗
• MalfunctionJun 3, 2020Fracture; Fracture

  AS REPORTED BY THE FIELD, DURING THE PREPPING OF A 100CM ENVOY 6F (67025800, 30202000) FOR A PERCUTANEOUS INTRACRANIAL ANEURYSM EMBOLIZATION, THE CATHETER WAS KINKED. THERE WAS NOT PATIENT INJURY REPORTED. THE PHYSICIAN CHANGED THE DEVICE FOR ANOTHER ONE TO COMPLETE THE OPERATION. THE DEVICE HAD NOT BEEN RE-SHAPED AFTER REMOVAL FROM PACKAGING. THE DEVICE HAD NOT BEEN INSERTED THROUGH A STOPCOCK INSTEAD OF THE HEMOSTASIS VALVE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE BODY/SHAFT WAS OBSERVED FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10114077 ↗
• MalfunctionJan 2, 2019Fracture; Fracture

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE MIDDLE PORTION OF THE 6F ENVOY MPD 100CM (67025800/17694731) GUIDE CATHETER WAS NOTED TO BE FRACTURED PRIOR TO USE IN THE PATIENT. THE UNSPECIFIED MICROCATHETER COULD NOT BE INSERTED DUE TO THE FRACTURE. THE DEVICE WAS NOT USED IN THE PATIENT; THEREFORE, NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208392 ↗
• InjuryDec 17, 2018Material Separation; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A BALLOON ANGIOPLASTY OF THE BASILAR ARTERY, A 6F ENVOY (67025800/30048285) GUIDE CATHETER BECAME BENT AND SEPARATED IN THE PATIENT. AFTER THE TIP OF 6F ENVOY CATHETER REACHED THE V2 END POSITION OF RIGHT VERTEBRAL ARTERY VIA A V-18 (BOSTON SCIENTIFIC) GUIDEWIRE, THE GUIDEWIRE WAS REMOVED. AN AVIGO (MEDTRONIC) MICRO-GUIDEWIRE WAS PLACED TO DELIVER THE 2.0 X 15MM GATEWAY (BOSTON SCIENTIFIC) BALLOON THROUGH THE ENVOY CATHETER, BUT IT WAS DIFFICULT TO ADVANCE. IT WAS DISCOVERED VIA FLUOROSCOPY THAT THE ENVOY GUIDE CATHETER WAS BENT. WHILE ATTEMPTING TO PULL THE CATHETER BACK, THE ENVOY CATHETER SEPARATED AND FELL INTO THE VESSEL. THE FALLEN PART WAS PULLED OUT THROUGH BILATERAL FEMORAL ARTERY APPROACH, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH PATIENT INJURY; HOWEVER, THE SPECIFIC INJURY WAS NOT SPECIFIED. THE SURGERY WAS DELAYED FIVE HOURS DUE TO THE EVENT. AFTER THE RECOVERY TREATMENT IN THE NEUROINTENSIVE CARE UNIT, THE PATIENT WAS AWAKE AND ABLE TO PERFORM SOME ACTIVITIES. THE COMPLAINT PRODUCT WAS NEW AND STORED/HANDLED ACCORDING TO THE LABELING INSTRUCTION

  Patient problems: Injury; No Code Available

  MAUDE report 8171443 ↗