Headway Duo MC162156SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00810170014345), received between Apr 23, 2018 and Sep 19, 2025 — classified as 1 death, 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 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.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJun 19, 2020Break; Break

  IT WAS REPORTED THAT TREATMENT WAS BEING PERFORMED FOR A LARGE AVM. AFTER THE MICROCATHETER (HEADWAY-DUO) WAS POSITIONED IN THE POSTERIOR CIRCULATION, THE MICROCATHETER LOST POSITION. DURING THE ATTEMPT TO WITHDRAW THE MICROCATHETER BACK, THE MICROCATHETER DETACHED COMPLETELY INSIDE THE GUIDE CATHETER. A BALLOON CATHETER WAS USED TO HOLD THE DETACHED SEGMENT TO THE GUIDE CATHETER TO REMOVE IT FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10177032 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM IN A TORTUOUS RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), A POSSIBLE VESSEL DISSECTION WAS IDENTIFIED. THERE WAS NO REPORTED ADDITIONAL INTERVENTION OR CLINICAL SEQUELA.

  Patient problems: Vascular Dissection

  MAUDE report 9729982 ↗
• DeathOct 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT-ASSISTED COILING OF A VERTEBRAL ARTERY ANEURYSM WAS ATTEMPTED. THE HEADWAY MICROCATHETER WAS PLACED ACROSS THE ANEURYSM NECK IN THE BASILAR ARTERY AND AN ATTEMPT WAS THEN MADE TO DEPLOY THE LVIS STENT. THE STENT OPENED DISTALLY AND THE DISTAL FLARED ENDS APPOSED WELL TO THE VESSEL WALL; HOWEVER, AFTER MORE THAN 40% OF THE STENT HAD BEEN DEPLOYED, IT DID NOT OPEN AT THE NECK OF THE ANEURYSM. AN ATTEMPT WAS MADE TO RE-SHEATH THE STENT; HOWEVER, THE ENTIRE STENT COULD NOT BE RECAPTURED INTO THE MICROCATHETER, SO THE ENTIRE STENT/MICROCATHETER SYSTEM WAS WITHDRAWN TOGETHER AS A SINGLE UNIT. AS THE SYSTEM WAS BEING REMOVED, IT MOVED THE HEADWAY THAT WAS POSITIONED IN THE ANEURYSM, AND THE ANEURYSM RUPTURED. PROTAMINE WAS ADMINISTERED IMMEDIATELY AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS TAKEN TO THE ICU FOR OBSERVATION AND AFTER A DAY, THE PATIENT DIED. ANEURYSM RUPTURE WAS DETERMINED TO BE THE CAUSE OF THE PATIENT'S DEATH.

  Patient problems: Death; Rupture

  MAUDE report 8011999 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE MICROCATHETER GOT STUCK IN THE ONYX AND BROKE OFF FROM THE REST OF THE MICROCATHETER AT THE 3 CM MARKER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT; HOWEVER, THE DISTAL TIP WAS LEFT IN THE PATIENT, ENTRAPPED IN THE ONYX. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7452626 ↗