HEADWAY MC162156S-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00842429117408), received between Mar 21, 2025 and Apr 16, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THE COILS WOULD NOT GO IN HEADWAY-DUO MICROCATHETER. THE CASE WAS COMPLETED BY USING A DIFFERENT DUO AND SAME TYPE OF COILS, JUST DIFFERENT LOT #¿S. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME IS STATED TO BE STABLE. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND EXPOSED LUMEN COIL AND PROTRUDING BRAID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898392 ↗
• MalfunctionMar 17, 2026Material Protrusion/Extrusion

  IT WAS REPORTED WERE UNABLE TO ADVANCE A WIRE THROUGH IT. OPENED UP ANOTHER HWDUO TO COMPLETE THE CASE. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED LUMEN COIL PROTRUDING INTO THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623798 ↗
• MalfunctionFeb 19, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN L ACOMM EMBOLIZATION CASE. TN COILS#1-10 WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUE WITH HEADWAY DUO#1. THE PHYSICIAN INSERTED AN ARISTOTLE 14 GUIDEWIRE, AFTER USING THE GUIDEWIRE SEVERAL TIMES TO RE-POSITION DURING THE CASE, WITH HEADWAY DUO#1 AFTER COIL#10 WAS DEPLOYED TO RE-POSITION ONCE AGAIN. THE ARISTOTLE 14 WOULD NOT ADVANCE INTO THE HEADWAY DUO#1. THE ARISTOTLE 14 WAS REMOVED, AND A SYNCHRO SOFT GUIDEWIRE WAS USED WITHOUT ISSUE TO RE-POSITION. PROCEDURE CONTINUED AND THEN COIL#11 WHICH WOULD NOT ADVANCE INTO THE HUB OF THE HEADWAY DUO #1, TN COIL#11 WAS SET ASIDE, AND A NEW HEADWAY DUO#2 WAS OPENED AND CASE CONTINUED WITH COIL#11 BEING INSERTED WITHOUT ISSUE. TN COIL#12 WAS INSERTED INTO HEADWAY DUO#2 AND WOULD NOT ADVANCE. COIL#12 WAS SET ASIDE, AND A NEW COIL WAS CHOSEN. TN COIL#13 WOULD ALSO NOT ADVANCE INTO HEADWAY DUO#2. BOTH HEADWAY DUO#2 AND COIL#13 WERE SET ASIDE FOR RETURN. HEADWAY DUO#3 WAS OPENED AND TN COIL#14 AND #15 INSERTED WITHOUT ISSUE. TN COIL#16 WOULD NOT ADVANCE IN HEADWAY DUO#3. COIL#16 SET ASIDE FOR RETURN. TN COIL#17 OPENED AND DEPLOYED WITHOUT ISSUE. TN COIL#18 ADVANCED INTO HEADWAY DUO#3 WITHOUT ISS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388907 ↗
• MalfunctionFeb 12, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CONCERNED MICROCATHETER WAS BEING USED IN AN MMA EMBOLIZATION PROCEDURE. REPORTEDLY, WHILE PREPPING THE MICROCATHETER, A 0.014 WIRE ATTEMPTED TO INSERTED INTO THE MICROCATHETER BUT THE WIRE WOULD NOT ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THE PHYSICIAN DECIDED TO USE A NEW MICROCATHETER OF THE SAME MODEL, WHICH PERFORMED AS DESIGNED SUCCESSFULLY. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE INVESTIGATION OF THE RETURNED DEVICE FOUND EXPOSED COIL PROTRUDING INTO THE LUMEN AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327410 ↗
• MalfunctionDec 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CONCERNED MICROCATHETER WAS USED IN AN UNSPECIFIED COIL EMBOLIZATION PROCEDURE. REPORTEDLY, THE COILS WOULD NOT ADVANCE IN THE MICROCATHETER. SOME DIFFERENT COILS' BRANDS WERE USED AND SOME WERE DELIVERED; OTHERS COULD NOT ADVANCE IN THE MICROCATHETER. EVENTUALLY A WIRE WAS NOT ABLE TO BE ADVANCED THRU THE CATHETER. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE INVESTIGATION OF THE RETURNED DEVICE FOUND EXPOSED COIL PROTRUDING INTO THE LUMEN AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897970 ↗
• MalfunctionDec 9, 2025Peeled/Delaminated; Material Protrusion/Extrusion; Peeled/Delaminated; Material Protrusion/Extrusion

  NO NEW INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764836 ↗
• MalfunctionAug 19, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS INITIALLY REPORTED, THE WIRE WOULD NOT GO THROUGH THE HUB OF THE MICROCATHETER, AND TEAM HAD TO BACKLOAD WIRE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, PROXIMAL MICROCATHETER SHAFT EXHIBITED INCOMPLETE FLARING WITH EXPOSED BRAID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846500 ↗
• InjuryAug 13, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PHYSICIAN USED GLUE (NBCA) TO EMBOLIZE THE VESSEL THROUGH THE MICROCATHETER. WHEN THEY ATTEMPTED TO REMOVE THE MICROCATHETER, THE GLUE POLYMERIZE AND HARDENED QUICKLY AROUND THE CATHETER, LEAVING IT STUCK. UPON TRYING TO REMOVE IT, THE CATHETER REMAINED STUCK. THE CATHETER WAS PULLED WITH FORCE, AND THEN IT BROKE. IT APPEARS THAT A PORTION OF THE BROKEN CATHETER THAT CAME OFF GOT STUCK IN THE GLUE. THE OTHER PORTION OF THE CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Foreign Body Embolism

  MAUDE report 22801266 ↗
• InjuryAug 6, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT, DURING A CSDH EMBOLIZATION PROCEDURE WITH THE USE OF ONYX AND A HEADWAY DUO MICROCATHETER, THE TIP OF ONE OF THE MICROCATHETERS BROKE OFF INSIDE THE PATIENT. THE MICROCATHETER BECAME EMBEDDED IN THE ONYX CAST LESS THAN 4 MINUTES AFTER THE START OF THE EMBOLIZATION, WITH THE EMBOLIC AGENT SURROUNDING IT DISTALLY FOR A MAXIMUM OF 3 MINUTES, THAT APPROXIMATELY 10-15 CM OF THE TIP BROKE OFF DURING REMOVAL AND REMAINED IN THE MIDDLE MENINGEAL ARTERY. CLINICALLY, THE INTRAVASCULAR REMNANT IN THIS LOCATION CURRENTLY HAS NO CONSEQUENCES FOR US. THERE WAS NO REPORTED INJURY OR INTERVENTION AND IT HAD NO INFLUENCE TO THE PATIENTS OUTCOME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734253 ↗
• MalfunctionJul 22, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INCLUDE RELATED MEDICAL DEVICE REPORT NUMBER IN SECTION H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567353 ↗
• MalfunctionJun 17, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: THEY WERE NOT ABLE TO LOAD THE TRAXCESS INTO THE CATHETER. INFORMATION RECEIVED NOTES IT IS A BIT UNCLEAR IF IT WAS STUCK IN THE HUB OR PROXIMAL PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED AS ANOTHER DUO CATHETER WAS USED WITHOUT PROBLEMS. THE SAME TRAXCESS WAS USED SUCCESSFULLY WITH THE NEW DUO CATHETER. THERE WAS NO PATIENT IMPACT, INJURY AND NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. PATIENT STATUS IS "GOOD". WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND THAT THE LUMEN COIL WAS DAMAGED AND EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235774 ↗
• MalfunctionJun 13, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE WIRE WOULD NOT GO THROUGH CATHETER AND HAD TO OPEN NEW CATHETER. THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND DELAMINATION AND EXPOSED LUMEN BRAID AT THE HUB JOINT OF THE MICROCATHETER. THEREFORE, THE COMPLAINT IS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200216 ↗
• MalfunctionJun 1, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A HEADWAY DUO MICROCATHETER WOULD NOT ACCEPT A GUIDEWIRE. A NEW CATHETER WAS SELECTED AND THE GUIDEWIRE WORKED WITH IT. THE DEVICE HAD NO PATIENT CONTACT. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND THE LUMEN TO NOT BE FULLY FLARED AT THE HUB JOINT WITH EXPOSED BRAID IN THE LUMEN, AND DELAMINATED PTFE WAS IN THE LUMEN. TWO OTHER CATHETERS FROM THE SAME CASE EXPERIENCED THE SAME ISSUE DURING PREP AND WERE REPORTED UNDER MDRS 2032493-2025-90167 AND 2032493-2025-90171.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121363 ↗
• MalfunctionMay 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: "THERE WERE MULTIPLE ISSUES ADVANCING THE WIRE." PATIENT IS OK AND DISCHARGED. WHEN THE DEVICE WAS RECEIVED AND INVESTIGATED, IT WAS FOUND THAT THE LUMEN BRAID WAS EXPOSED AT THE HUB JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089688 ↗
• MalfunctionMay 20, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A HEADWAY DUO MICROCATHETER WOULD NOT ACCEPT A GUIDEWIRE. A NEW CATHETER WAS SELECTED AND THE GUIDEWIRE WORKED WITH IT. THE DEVICE HAD NO PATIENT CONTACT. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND THE LUMEN TO NOT BE FULLY FLARED AT THE HUB JOINT WITH EXPOSED BRAID IN THE LUMEN, AND DELAMINATED PTFE WAS IN THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057847 ↗
• InjuryApr 23, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  AS REPORTED: HEADWAY DUO 156CM WAS BEING USED IN A FACIAL AVM TREATMENT, AROUND THE FACIAL ARTERY, SO NOT INTRACRANIAL. THE HEADWAY DUO PERFORMED AS EXPECTED FOR ABOUT 15 MINUTES OF THE CASE. THE LIQUID EMBOLIC WAS BEING USED AND EVERYTHING WAS FINE UNTIL THE END OF THE CASE AND FINISHED EMBOLIZING. AS THE HEADWAY DUO WAS BEING PULLED BACK, THEY NOTICED A GREAT DEAL OF RESISTANCE, HOLDING THE HEADWAY DUO IN. THE GUIDE CATHETER AND THE INTERMEDIATE CATHETER WERE ADVANCED AS THEY PULLED THE HEADWAY DUO, BUT THE HEADWAY DUO BROKE, LEAVING THE DISTAL 15MM LODGED IN THE ARTERY. ASSESSING THE SITUATION, THEY DECIDED TO PUSH THE DETACHED TIP OF THE HEADWAY DUO INTO THE FACIAL ARTERY WHERE THEY WERE SATISFIED IT WOULD STAY. THE PATIENT WAS DISCHARGED THE SAME DAY WITHOUT ISSUE. NO HARM TO THE PATIENT. NO BLOOD LOSS. NO DEVICE TO RETURN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896323 ↗
• MalfunctionApr 20, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE DEVICE, TWO MICROCATHETERS WOULD NOT ACCEPT A GUIDEWIRE THROUGH BOTH UNITS. THE WIRE WAS GETTING STUCK AROUND THE HUB SECTION AND WOULD NOT ADVANCE. THE MICROCATHETER WAS NOT USED AND A NEW MICROCATHETER WITH A DIFFERENT LOT NUMBER WAS USED TO CONTINUE THE PROCEDURE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED; IT WAS FOUND THAT THE CATHETER SHAFT EXHIBITED INCOMPLETE FLARING WITH EXPOSED BRAID AT THE HUB TRANSITION. THE DEVICE ASSOCIATED WITH THIS REPORT WAS USED DURING THE SAME PROCEDURE REFERENCED IN MFR. REPORT# 2032493-2025-90089.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870431 ↗
• MalfunctionApr 20, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE DEVICE, TWO MICROCATHETERS WOULD NOT ACCEPT A GUIDEWIRE THROUGH BOTH UNITS. THE WIRE WAS GETTING STUCK AROUND THE HUB SECTION AND WOULD NOT ADVANCE. THE MICROCATHETER WAS NOT USED AND A NEW MICROCATHETER WITH A DIFFERENT LOT NUMBER WAS USED TO CONTINUE THE PROCEDURE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED; IT WAS FOUND THAT THE CATHETER SHAFT EXHIBITED INCOMPLETE FLARING WITH EXPOSED BRAID AT THE HUB TRANSITION. THIS REPORT ADDRESSES THE FIRST MICROCATHETER. THE OTHER MICROCATHETER WILL BE SUBMITTED UNDER A SEPARATE MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870420 ↗
• MalfunctionMar 27, 2025Contamination; Material Protrusion/Extrusion; Contamination; Material Protrusion/Extrusion

  THE COIL WOULD NOT GO THROUGH THE HUB OF THE DUO CATHETER. THERE WAS ALSO A THIN THREAD COMING OUT OF THE HUB OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715559 ↗
• MalfunctionMar 21, 2025Contamination; Contamination

  AS REPORTED, THE HEADWAY DUO CATHETER WAS INTRODUCED INTO THE SUPPORT CATHETER AND THE .014 ARISTOTLE WIRE WHICH HAD PREVIOUSLY GONE THROUGH THE HEADWAY DUO CATHETER WITH NO ISSUES WOULDN'T ADVANCE THROUGH THE HEADWAY DUO CATHETER. CATHETER AND WIRE WERE REMOVED FROM THE PATIENT AND HEP SALINE WAS FLUSHED THROUGH THE DUO WITH MUCH DIFFICULTY, AND WHEN THE HEP SALINE FINALLY CAME OUT A SMALL PIECE OF SOMETHING WHITE FLUSHED OUT WITH IT. WE WERE UNABLE TO RETAIN THE WHITE OBJECT AS IT WAS EXTREMELY SMALL AND GOT LOST WHILE ATTEMPTING TO RETAIN IT. IT WAS OUTSIDE OF THE PATIENT AT THAT TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PATIENT OUTCOME IS REPORTED AS "GOOD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665677 ↗