Headway Duo MC162167SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00810170014413), received between Mar 17, 2016 and Apr 18, 2025 — classified as 2 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Unintended Movement; Unintended Movement

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866667 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EMBOLIZATION OF A LEFT AICA-AVM WAS PERFORMED SUCCESSFULLY WITH HEADWAY DUO AND PHIL 25%. WHEN WITHDRAWING THE HEADWAY DUO, THE BASILAR ARTERY RUPTURED. THE CAUSE OF THE RUPTURE IS NOT KNOWN. THE PHYSICIAN STATED THAT THERE WAS SOME TENSION ON THE HEADWAY DUO, POSSIBLY CAUSED BY TORTUOUS ANATOMY. THE PATIENT UNDERWENT SUCCESSFUL SURGERY FOR PRESSURE RELIEF AND IS IN INTENSIVE CARE.

  Patient problems: Intracranial Hemorrhage; Rupture

  MAUDE report 11682727 ↗
• InjuryDec 22, 2020Break; Entrapment of Device; Difficult to Remove; Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING AN AVM EMBOLIZATION WITH A LIQUID EMBOLIC, THE CATHETER BECAME ENTRAPPED IN THE EMBOLIC AND DETACHED IN THE PATIENT DURING REMOVAL. THE CATHETER WAS SURGICALLY REMOVED. THE PATIENT IS CURRENTLY DOING WELL AND THERE WAS NO REPORTED SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11061485 ↗
• InjuryNov 5, 2020Break; Entrapment of Device; Difficult to Remove; Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE USING THE ONYX LIQUID EMBOLIC, THE MICROCATHETER WAS CAPTURED IN SOLIDIFIED EMBOLIC AND SEPARATED AS IT WAS BEING REMOVED FROM THE ONYX CONSTRUCT. THE SEPARATED REMNANT OF THE MICROCATHETER WAS ASPIRATED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10795732 ↗
• InjuryJun 28, 2019Break; Break

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INFRAORBITAL ARTERIOVENOUS MALFORMATION (AVM). THE HEADWAY DUO MICROCATHETER WAS ADVANCED THROUGH THE OPHTHALMIC ARTERY TO A SATISFACTORY POSITION CLOSE TO THE AVM. AN INJECTION OF PHIL LIQUID EMBOLIC WAS DELIVERED TO THE TREATMENT SITE THROUGH THE HEADWAY DUO. AFTER COMPLETION OF THE INJECTION, THE MICROCATHETER WAS PULLED BACK AND A "STRETCHING FEELING" OCCURRED. UPON REMOVAL OF THE MICROCATHETER FROM THE PATIENT, THE DISTAL TIP WAS NOTED TO BE MISSING. DSA IMAGING DEMONSTRATED SOME "MATERIAL" IN THE M1 PORTION OF THE MIDDLE CEREBRAL ARTERY (MCA), WHICH WAS IDENTIFIED AS PHIL AND PART OF THE HEADWAY DUO. THE DECISION WAS MADE TO TREAT THE PATIENT WITH ASPIRIN AND FINISH THE PROCEDURE. APPROXIMATELY 30 MINUTES POST-PROCEDURE, THE PATIENT WAS HEMIPARETIC DUE TO THROMBUS IN THE MCA AND SUBSEQUENT CVA. ANOTHER PROCEDURE WAS PERFORMED TO ATTEMPT TO ASPIRATE THE MATERIAL IDENTIFIED AT THE MCA WITH A SOFIA CATHETER; HOWEVER, IT WAS UNSUCCESSFUL. ANOTHER ATTEMPT TO REMOVE THE MATERIAL WAS MADE WITH A SOLITAIRE STENT RETRIEVER, BUT THAT WAS ALSO UNSUCCESSFUL. A SCEPTER BALLOON WAS THEN USED TO ATTEMPT TO MOVE THE MATERIAL; HOWEVER, DURIN

  Patient problems: Paresis; Thrombus; Vascular System (Circulation), Impaired

  MAUDE report 8746647 ↗
• DeathDec 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEADACHE AND WAS NEUROLOGICALLY INTACT. A CT AND SUBSEQUENT ANGIOGRAM CONFIRMED A RUPTURED LEFT PICA AVM. THE DECISION WAS MADE TO EMBOLIZE THE AVM WITH ONYX. TREATMENT WAS PERFORMED ON FRIDAY, (B)(6) 2017. THE PATIENT WAS REPORTED TO HAVE BEEN ANTICOAGULATED. ACCESS TO THE AVM WAS EASILY ESTABLISHED FROM THE LEFT VERTEBRAL ARTERY USING A 6F SHUTTLE GUIDING SHEATH, A SOFIA 5F CATHETER, AND A 167CM HEADWAY DUO MICROCATHETER. THE ONYX WAS DELIVERED THROUGH THE HEADWAY WITHOUT COMPLICATION, WHICH RESULTED IN COMPLETE EMBOLIZATION OF THE AVM; HOWEVER, THE HEADWAY WAS UNABLE TO BE REMOVED FROM THE CAST OF THE ONYX. A TECHNIQUE TO GENTLY EASE THE HEADWAY FROM THE ONYX WAS EMPLOYED BY APPLYING A LITTLE TENSION TO THE HEADWAY AND RETRACTING IT APPROXIMATELY 1 CM; THE TOUHY WAS THEN TIGHTENED AROUND THE HEADWAY FOR APPROXIMATELY 3 MINUTES. AFTERWARD, THE HEADWAY WAS RETRACTED ANOTHER 1 CM FOR ANOTHER MINUTE, THE TOUHY WAS TIGHTENED, AND THE HEADWAY FINALLY FREED FROM THE ONYX. UPON REMOVAL OF THE HEADWAY, THE LAST CM OF THE DISTAL END WAS MISSING. THE TIP WAS NOT VISIBLE UNDER FLUOROSCOPY, AND IT WAS SUSPECTED TO BE ENCASED IN THE ONYX. THER

  Patient problems: Death; Infarction, Cerebral; Thrombus

  MAUDE report 7077371 ↗
• DeathNov 20, 2017Fracture; Material Fragmentation

  ENDOVASCULAR EMBOLIZATION. AS PER THE USUAL NEUROINTERVENTIONAL APPROACH TO AVMS, WE POSITIONED A MICROCATHETER (A 167 CM HEADWAY DUC) CLOSE TO THE AVM IN PREPARATION FOR EMBOLIZATION WITH A LIQUID EMBOLIC AGENT KNOWN AS ONYX. ONYX FUNCTIONS AS A SORT OF INJECTABLE GLUE, AND EMBOLIZATION OF BRAIN AVMS IS AN ON-LABEL USE OF THIS PRODUCT. FURTHER THE HEADWAY DUO IS MARKETED FOR ITS COMPATIBILITY WITH ONYX AND DMSO (AN AGENT USED IN CONJUNCTION WITH ONYX). THE EMBOLIZATION WENT AS PLANNED, AND THE AVM APPEARED TO BE COMPLETELY ELIMINATED. UPON ATTEMPTING TO REMOVE THE MICROCATHETER FROM THE HARDENED ONYX, AGAIN IN THE STANDARD FASHION, THE MICROCATHETER FRACTURED. WE NOTED THAT THE RETRIEVED PORTION OF THE MICROCATHETER ACCOUNTED FOR ALMOST ITS ENTIRE LENGTH, AND THEREFORE THAT THE RETAINED FRAGMENT OF MICROCATHETER WAS SMALL AND LIKELY EMBEDDED IN THE ONYX, WHERE IT WOULD CAUSE NO HARM. THE CASE WAS THEREFORE CONCLUDED AND THE PT AWOKEN FROM ANESTHESIA. SHE AWOKE NORMALLY AND WAS AGAIN NOTED TO BE NEUROLOGICALLY INTACT. APPROX 1 HR LATER, THE PT EXPERIENCED A CLINICAL DETERIORATION. HEAD CT WAS PERFORMED EMERGENTLY AND DEMONSTRATED HIGH DENSITY MATERIAL IN THE BASILAR ARTERY. WE THEN

  Patient problems: Death; Device Embedded In Tissue or Plaque; Infarction, Cerebral

  MAUDE report 7048103 ↗
• MalfunctionAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A MICROCATHETER PASSED THE PRE-TEST; HOWEVER, THE PROXIMAL PORTION OF THE MICROCATHETER BROKE DURING USE. THE ENTIRE MICROCATHETER WAS REMOVED IN ITS ENTIRETY. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6830326 ↗
• MalfunctionMar 17, 2016Leak/Splash; Device Issue; Leak/Splash; Device Issue

  IT WAS REPORTED THAT DURING A DURAL ARTERIOVENOUS FISTULA (DAVF), ONYX 34 INJECTION WAS PERFORMED. NOTED REFLUX AROUND CATHETER TIP WAS REPORTED. UPON REMOVAL OF THE CATHETER IT WAS OBSERVED THAT THE CATHETER TIP HAD TORN. NO HARM OR INJURY OCCURRED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5507745 ↗