ENVOYRecalls & reported problems across all models

We found 15 models of ENVOY by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2017 and Jun 16, 2026 — classified as 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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

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

• ENVOY 670-258-00

  CATHETER, PERCUTANEOUS
  12 reports
• ENVOY 670-258-90

  CATHETER, PERCUTANEOUS
  4 reports
• ENVOY 556-256-00

  CATHETER, PERCUTANEOUS
  3 reports
• ENVOY 670-256-00

  CATHETER, PERCUTANEOUS
  3 reports
• ENVOY 670-256-00B

  CATHETER, PERCUTANEOUS
  3 reports
• ENVOY 670-256-90B

  CATHETER, PERCUTANEOUS
  3 reports
• ENVOY 670-256-90

  CATHETER, PERCUTANEOUS
  2 reports
• ENVOY 670-260-90

  CATHETER, PERCUTANEOUS
  2 reports
• ENVOY 556-258-00

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 556-258-90

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 670-252-90

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 670-258-90B

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 670-260-00B

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 778-258-90

  CATHETER, PERCUTANEOUS
  1 report
• ENVOY 778-252-90

  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.

• 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 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem; Physical Resistance/Sticking

  ON (B)(6) 2026, DURING AN EMBOLIZATION PROCEDURE TARGETING THE MIDDLE MENINGEAL ARTERY, UPON THE INSERTION OF THE 6F 90 CM, STRAIGHT ENVOY® GUIDING CATHETER (67026090 / 31740728), THERE WAS STRONG RESISTANCE BETWEEN THE ENVOY AND THE INNER CATHETER STARTING AROUND THE OPHTHALMIC ARTERY (AO). CONTINUOUS FLUSH WAS MAINTAINED. THE VESSEL COURSE WAS TORTUOUS. WHEN THE ENVOY WAS WITHDRAWN, AN UNIDENTIFIED MATERIAL WAS FOUND ATTACHED TO IT. THE ENVOY WAS REPLACED WITH A NEW ENVOY OF THE SAME SIZE, AND THE REPLACEMENT ENVOY CATHETER WAS USED WITH THE SAME INNER CATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 09-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION PROVIDED INCLUDES THE PHYSICIAN¿S COMMENTS ON THE REPORTED ISSUE AND DETAILS RELATED TO THE PROCEDURE. ¿THE AORTIC TORTUOSITY APPEARED TO HAVE SEVERAL MARKEDLY TORTUOUS SEGMENTS, WHICH I BELIEVE WAS ONE OF THE FACTORS CAUSING RESISTANCE DURING CATHETER INSERTION. THE TORTUOSITY AT THE [COMMON CAROTID ARTERY] CCA ORIGIN WAS SUCH THAT IT BENT ABOUT 90 DEGREES IMMEDIATELY AFTER ITS ORIGIN, AND I THOUGHT THIS WAS FAIRLY PRONOUNCED. THE INNER CATHETER U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415999 ↗
• InjuryFeb 19, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED, VIA EMAIL, THAT AN ENVOY, 7F, 90 CM, SIMMONS 2 (77825290/ 31708615) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED ENVOY CATHETER- WITHDRAWAL DIFFICULTY FROM VESSEL AND SEPARATION WHILE IN PATIENT. THE PHYSICIAN USED A ZOOM55 REPERFUSION CATHETER (IMPERATIVE CARE, INC.) INSIDE THE ENVOY AND HAD AN 8FR SHEATH (UNSPECIFIED BRAND) FOR FEMORAL ACCESS. DUE TO SEVERE VESSEL TORTUOSITY, THE USER WAS ¿UNABLE TO SELECT TO ADVANCE.¿ THE PHYSICIAN DECIDED TO WITHDRAW THE ENVOY CATHETER BUT EXPERIENCED DIFFICULTY/RESISTANCE. ¿CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT.¿ THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿AFTER TRYING TO SELECT IN A TYPE III ARCH WITH VERY TORTUOSITY VESSELS, UNABLE TO SELECT TO ADVANCE. WHEN, PHYSICIAN DECIDED TO PULL THE 7FR ENVOY CATHETER SIM 2 BY 90CM LENGTH, IT WAS HARD TO PULL CATHETER. CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT. PHYSICIAN HAD USED A ZOOM 55 INSIDE THE ENVOY AND HAD AN 8FR SHEATH FOR FEMORAL ACCESS.¿ ON 14-FEB-2026, ADDITIONAL EVENT INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE. SUMMARY: PER THE INFORMATION PROVIDED, IT WAS CONFIRMED THAT THE CATHETER ST

  Patient problems: Insufficient Information

  MAUDE report 24388305 ↗
• MalfunctionFeb 2, 2026Crack; Material Twisted/Bent

  IT WAS REPORTED, VIA EMAIL, THAT AN ENVOY 6F, XB MPD 90CM (67025890B / 31663293), WAS TO BE USED FOR A CAROTID STENTING PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED A KINK AND A CRACK OF THE ENVOY. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PRODUCT ARRIVED BROKEN IN ITS ORIGINAL PACKAGING. THE PRODUCT WAS INTENDED FOR USE IN A CAROTID STENTING PROCEDURE, BUT DUE TO DAMAGE TO THE PRODUCT, IT WAS NOT USED IN THE PATIENT, CAUSING A DELAY IN THE PROCEDURE. THE DEVICE HAS BENDING/BREAKAGE. THE DAMAGE WAS NOTICED BEFORE THE PRODUCT WAS USED ON THE PATIENT. NOTHING WAS OBSTRUCTING THE CATHETER. THE CATHETER WAS NOT FLUSHED. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234375 ↗
• 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 ↗
• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554596 ↗
• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554557 ↗
• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554501 ↗
• 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 ↗
• MalfunctionFeb 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, BOTH ENVOY 6F, MPC 100CM CATHETERS (67025600, 31027256) HAD PROTRUDING PLASTIC RESIDUES FROM PRODUCTION ON THE THREADED PIECE. THE PROFESSOR DID NOT WANT TO USE THEM DUE TO THE RISK OF EMBOLIZATION. WE NOTICED THIS PROBLEM WHEN UNPACKING, SO THERE IS NO RISK OF INFECTION. NO PATIENT INJURY AS THE DEVICES WERE NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-FEB-2025 INDICATED THAT THE POUCHES WERE SEALED PRIOR TO BEING OPENED. THERE WAS NOT BEEN ANY PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364576 ↗
• MalfunctionFeb 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, BOTH ENVOY 6F, MPC 100CM CATHETERS (67025600, 31027256) HAD PROTRUDING PLASTIC RESIDUES FROM PRODUCTION ON THE THREADED PIECE. THE PROFESSOR DID NOT WANT TO USE THEM DUE TO THE RISK OF EMBOLIZATION. WE NOTICED THIS PROBLEM WHEN UNPACKING, SO THERE IS NO RISK OF INFECTION. NO PATIENT INJURY AS THE DEVICES WERE NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-FEB-2025 INDICATED THAT THE POUCHES WERE SEALED PRIOR TO BEING OPENED. THERE WAS NOT BEEN ANY PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364536 ↗
• MalfunctionJan 24, 2025Crack; Crack

  AS REPORTED BY THE FIELD, WHEN UNPACKING THE ENVOY CATHETER (77825890, 31253144) THE HEALTH CARE PROFESSIONAL (HCP), NOTICED THAT IT WAS TORN AT THE TOP OF THE HUB AND THEN PLACED IT ON ITS SIDE. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JAN-2025 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230911 ↗
• MalfunctionDec 26, 2024Material Puncture/Hole; Material Puncture/Hole

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A ¿HOLE IN THE CATHETER.¿ THE CATHETER REPORTED WAS AN ENVOY® XB GUIDING CATHETER (67026000B / 31189199). THE ISSUE WAS OBSERVED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. ON 12-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ISSUE OCCURRED ON (B)(6) 2024 PRE-OP TO A CEREBRAL DIAGNOSTIC PROCEDURE. THE ENVOY WAS REPLACED WITH ANOTHER ENVOY GUIDING CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO NEGATIVE PATIENT IMPACT AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019793 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, THERE WAS A HUB LEAKAGE ON AN ENVOY 5F, MPD 90CM CATHETER (55625890, 31189193) WHEN IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843990 ↗
• MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE TARGETING AN ARTERIOVENOUS MALFORMATION (AVM), THE PHYSICIAN WAS GAINING ACCESS TO THE ARTERY WHILE ADVANCING A 6F 90 CM, STRAIGHT ENVOY® GUIDING CATHETER (67026090 / 31040775) WHEN IT WAS NOTICED THAT BLOOD WAS LEAKING AROUND THE HUB OF THE CATHETER WHERE THE YELLOW HUB MEETS THE WHITE ID BAND. THE ENVOY WAS REMOVED AND REPLACED WITH A NEW ONE AND THE PROCEDURE WENT FORWARD SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 04-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE AVM AND VESSEL CHARACTERISTICS (VESSEL TORTUOSITY OR ACUTE BENDS) ARE NOT KNOWN. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY (67026090).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613941 ↗

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