Headway DuoRecalls & reported problems across all models

We found 2 models of Headway Duo by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2016 and Sep 19, 2025 — classified as 3 deaths, 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (9 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 Headway Duo problems

Headway Duo models

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

• Headway Duo MC162167S

  CATHETER, PERCUTANEOUS
  2 deaths15 reports
• Headway Duo MC162156S

  CATHETER, PERCUTANEOUS
  1 death12 reports

Recent Headway Duo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS INITIALLY REPORTED, DURING A PROCEDURE FOR A MCA ANEURYSM (3MM X 2.7MM), THE PHYSICIAN NOTICED RESISTANCE WHILE ADVANCING THE GUIDEWIRE INTO THE HEADWAY DUO MICROCATHETER, DESPITE IT BEING PROPERLY HYDRATED BEFORE USE. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE WITH A NEW ONE. THE PHYSICIAN CHANGED ANOTHER NEW HEADWAY DUO MICROCATHETER TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE GOOD. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED EXPOSED COIL AT THE HUB TRANSITION AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099559 ↗
• MalfunctionJun 2, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE WIRE WOULD NOT PASS THE HUB. THERE WAS NO PATIENT INJURY NOR SURGICAL INTERVENTION REPORTED. THE PATIENT IS IN GOOD CONDITION. ALTHOUGH THE INITIAL INFORMATION RECEIVED WAS NOT DETERMINED TO BE REPORTABLE, WE ARE NOW REPORTING THE EVENT BASED ON DEVICE INVESTIGATION FINDINGS OF THE MICROCATHETER LUMEN WAS FOUND TO HAVE DAMAGED PTFE LINER AND AN EXPOSED BRAID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128552 ↗
• InjuryApr 18, 2025Unintended Movement; Unintended Movement

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866667 ↗
• InjuryNov 8, 2024Material Disintegration; Entrapment of Device; Material Disintegration; Entrapment of Device

  AS REPORTED THROUGH THE TECHNICAL VIDEO, JOURNAL ARTICLE TITLED, ¿MANAGEMENT OF A FRACTURED MICROCATHETER DURING MIDDLE MENINGEAL ARTERY EMBOLIZATION¿, HERE WE DESCRIBE THE MANAGEMENT OF A RETAINED AND FRACTURED MICROCATHETER FOLLOWING LIQUID EMBOLIC FOR MIDDLE MENINGEAL ARTERY EMBOLIZATION (MMAE). A PATIENT WITH CHRONIC RECURRENT SUBDURAL HEMATOMAS UNDERWENT BILATERAL MMAE WITH A COMPETITOR LIQUID EMBOLIC MATERIAL. THE HEADWAY DUO MICROCATHETER WAS PLACED IN A SMALL DISTAL FRONTAL BRANCH OF THE MIDDLE MENINGEAL ARTERY TO AID IN REFLUX INTO THE POSTERIOR MIDDLE MENINGEAL ARTERY BRANCHES. FOLLOWING SUCCESSFUL MMAE, THE MICROCATHETER BECAME TRAPPED WITHIN THE LIQUID EMBOLIC MATERIAL CAST AND, ON ATTEMPTED REMOVAL, THE MICROCATHETER FRACTURED, RESULTING IN A RETAINED FRAGMENT EXTENDING FROM THE MIDDLE MENINGEAL ARTERY CAST TO THE GUIDE CATHETER IN THE COMMON CAROTID ARTERY. TO RETRIEVE THE FRACTURED MICROCATHETER, A STENT RETRIEVER WAS DEPLOYED AND RE-SHEATHED MULTIPLE TIMES UNTIL THE RETAINED MICROCATHETER BECAME VISIBLY ENTANGLED WITH THE STENT RETRIEVER. NEXT, THE STENT RETRIEVER WAS PULLED BACK INTO THE GUIDE CATHETER AND CONTINUOUS ASPIRATION WAS PERFORMED THROUGH THE GUIDE CATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646693 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED: PATIENT DIAGNOSED WITH DAVF. PHYSICIAN DECIDED TO TREAT IT WITH LIQUID EMBOLIC. USED GUIDING SHEATH AND GUIDE CATHETER RESPECTIVELY. HEADWAY DUO 167 TAKEN AS MICROCATHETER AND NAVIGATED INTO THE DAVF OVER GUIDEWIRE. WHILE INJECTING THE FIRST VIAL OF LIQUID EMBOLIC THROUGH HEADWAY DUO167, PHYSICIAN OBSERVED THAT THE LIQUID EMBOLIC IS LEAKING OUT FROM THE MICROCATHETER. SO, PHYSICIAN IMMEDIATELY TOOK OUT THE HEADWAY DUO 167 MICROCATHETER. FINALLY, PHYSICIAN TOOK 2 VIALS OF LIQUID EMBOLIC AND EMBOLIZED THE DAVF THROUGH (NON-MVI) MICROCATHETER. ALL FINAL DSA RUNS WERE CLEAR AND HENCE PHYSICIAN DECIDED TO STOP THE PROCEDURE. CASE COMPLETION WAS SATISFACTORY. THERE WAS NO OTHER INTERVENTION PERTAINING TO THE LEAK BESIDES THE MICROCATHETER REMOVAL. PATIENT WAS EXTUBATED WITH ALL LIMBS MOVING AND OBEYING ALL COMMANDS OF TREATING PHYSICIAN. PROCEDURE: EMBOLIZATION WITH LES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072497 ↗
• InjuryJul 22, 2024Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT AN MMA EMBOLIZATION WAS BEING PERFORMED WITH LIQUID EMBOLIC. UPON DELIVERING THE EMBOLIC TO THE TREATMENT ZONE, THE PHYSICIAN TRIED TO REMOVED THE CATHETER AND COULD NOT AS THE GLUE ADHERED TO THE TIP OF THE HEADWAY DUO MICROCATHETER. AFTER PULLING HARD, THE CATHETER FRACTURED AND THE DISTAL PORTION REMAINED IN THE PATIENT. THE PROXIMAL REMAINDER WAS REMOVED. IT WAS REPORTED THAT INTERVENTION WAS PERFORMED. TWO DAYS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH A MIDLINE SHIFT AND IS NOW REPORTED TO BE IN A DETERIORATING CONDITION AS THE BRAIN IS NOW SWOLLEN AND HAS A BUILDUP OF PRESSURE.

  Patient problems: Brain Injury; Intracranial Pressure Increased

  MAUDE report 19801754 ↗
• MalfunctionApr 2, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE HEADWAY DUO MICROCATHETER WAS USED WITH A NON-MICROVENTION LIQUID EMBOLIC SYSTEM IN A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE. THE ANTERIOR AND POSTERIOR DIVISIONS ON THE LEFT MMA EMBOLIZATION COMPLETED SUCCESSFULLY. DURING EMBOLIZATION OF THE ANTERIOR DIVISION OF THE RIGHT MMA, EMBOLIZATION LIQUID WAS NOTED ON FLUOROSCOPY TO COME OUT IN THE PROXIMAL MMA. THE PROCEDURE WAS THEN ABORTED. NO REPORT OF INJURY TO THE PATIENT, WHO WOKE UP WELL. NO REPORT OF FUTURE PLANS TO TREAT THE RIGHT MMA. ON THE TABLE, THE LIQUID EMBOLIC WAS NOTED TO EXIT THE DISTAL TIP OF THE MICROCATHETER, BUT WHEN THE DISTAL TIP OF THE MICROCATHETER WAS OCCLUDED WITH FINGER PRESSURE, THERE WAS NO OBVIOUS EMBOLIC LEAK. ANATOMY WAS UNREMARKABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026433 ↗
• InjuryMar 15, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  AS REPORTED, HEADWAY DUO 167CM BECAME STUCK DURING MMA EMBOLIZATION WITH ONYX. THEN BROKE AND PULLED APART. APPX 10CM OF THE HEADWAY DUO IS STILL IN THE PATIENT AT THE EXTERNAL CAROTID ARTERY. THE PATIENT WOKE UP OK WITH NO PROBLEMS AND WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918732 ↗
• MalfunctionOct 2, 2023Break; Material Separation; Break; Material Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858154 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE DOCTOR ATTEMPTED TO REMOVE THE CATHETER FROM INSIDE THE PATIENT¿S SUPERIOR TEMPORAL VEIN, THE CATHETER TIP BROKE OFF AS THE DOCTOR ATTEMPTED TO REMOVE IT FROM THE AREA WHERE THEY WERE EMBOLIZING. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741887 ↗
• InjuryAug 4, 2023Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE HEADWAY CATHETER WAS USED TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) WITH PHIL LIQUID EMBOLIC THROUGH THE MICROCATHETER. DURING THE PROCEDURE, THE EMBOLIC REFLUXED AROUND THE CATHETER TIP, AND WAS UNABLE TO BE REMOVED. THE DECISION WAS MADE TO CUT THE CATHETER AT THE GROIN AND LEAVE INSIDE OF THE PATIENT. THE PATIENT WENT TO ICU AFTER THE PROCEDURE, CURRENTLY IN THE HDU, AND IS EXPECTED TO BE MOVED TO THE WARD LATER IN THE WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467013 ↗
• InjuryNov 7, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT PHIL LIQUID EMBOLIC WAS USED TO TREAT AN AVM AND WAS DELIVERED THROUGH A HEADWAY DUO MICROCATHETER AFTER THE MICROCATHETER WAS PLACED IN THE AVM FEEDER ARTERY. IT WAS REPORTED THAT THERE WAS INITIALLY SOME RESISTANCE DURING INJECTION. THE PHIL WAS ALLOWED TO REFLUX OVER THE CATHETER TIP 3CM. THE PHYSICIAN ATTEMPTED TO REMOVE THE HEADWAY DUO MICROCATHETER AFTER 3 MINUTES HAD PASSED SINCE THE PHIL WAS INJECTED. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE MICROCATHETER AND THE PHYSICIAN APPLIED RESISTANCE THREE TIMES IN ORDER TO REMOVE IT. IT WAS FIRST THOUGHT THAT THE MICROCATHETER WAS REMOVED BECAUSE THE CATHETER HAD COME OUT OF THE FEMORAL SHEATH, BUT ANGIOGRAPHY CONFIRMED THAT THE DUO HAD SEPARATED AND THE DISTAL PORTION WAS LEFT IN THE PATIENT DOWN TO THE CAROTID ARTERY. THE PATIENT WAS CONSCIOUS RIGHT AFTER EMBOLIZATION BUT ANGIOGRAPHY REVEALED A SMALL BLEED IN THE AREA OF EMBOLIZATION. THE PHYSICIAN THEN TOOK FOLLOW-UP ANGIOGRAPHY EVERY TWO HOURS AND FOUND THE BLEEDING WORSENED. THE PATIENT WAS TAKEN TO EMERGENCY SURGERY AROUND MIDNIGHT OF OCT. 1ST. VENTRICULOSTOMY WAS PERFORMED TO CONTROL INTRACRANIAL PRESSURE. HEMATOMA REMOVAL SURGERY WAS PERFORMED O

  Patient problems: Hematoma; Intracranial Hemorrhage; Ischemia Stroke; Loss of consciousness

  MAUDE report 12756108 ↗
• InjurySep 10, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION WITH ONYX LIQUID EMBOLIC, THE TIP OF THE HEADWAY DUO CATHETER GOT STUCK IN THE ONYX CAST AND BROKE OFF IN THE RIGHT MMA DUE TO EXCESS REFLUX ALONG THE CATHETER THAN INTENDED. THE BROKEN PIECE WAS LEFT IN THE PATIENT. THE RIGHT MMA BRANCH WAS TOTALLY BLOCKED OFF AS EXPECTED AND PHYSICIAN CONTINUED TO EMBOLIZE THE LEFT MMA AND PROCEDURE COMPLETED WITHOUT ANY ISSUES. REPORTEDLY, THE PATIENT WOKE UP FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453869 ↗
• MalfunctionJul 30, 2021Break; Entrapment of Device; Difficult to Remove; Material Separation; Break; Entrapment of Device; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT UPON REMOVAL OF THE CATHETER FROM THE INTENDED EMBOLIZATION SITE IN THE PATIENT'S LEFT MIDDLE MENINGEAL ARTERY (MMA), ONYX LEAKED OUT OF THE CATHETER CAUSING THE CATHETER TO STRETCH AND SNAP OFF. A PIECE OF THE MICROCATHETER WAS RETAINED INSIDE THE PATIENT'S ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256991 ↗
• MalfunctionJun 30, 2021Break; Leak/Splash

  UPON REMOVAL OF THE CATHETER FROM THE INTENDED EMBOLIZATION SITE IN THE PATIENT'S MIDDLE MENINGEAL ARTERY, ONYX LEAKED OUT OF THE CATHETER CAUSING THE CATHETER TO STRETCH AND SNAP OFF. PIECE OF THE MICROCATHETER WAS RETAINED INSIDE THE PATIENT'S ARTERY.

  Patient problems: Insufficient Information

  MAUDE report 12091809 ↗

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