HEADWAYRecalls & reported problems across all models

We found 10 models of HEADWAY by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2019 and Sep 23, 2026 — classified as 12 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (35 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 problems

HEADWAY models

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

• HEADWAY MC162156S-AL

  Catheter, intravascular, diagnostic
  20 reports
• HEADWAY MC212156S-AL

  Catheter, percutaneous
  9 reports
• HEADWAY MC272156S-AL

  Catheter, percutaneous
  7 reports
• Headway MC272156S

  CATHETER, PERCUTANEOUS
  3 reports
• HEADWAY MC162167S-AL

  Catheter, intravascular, diagnostic
  3 reports
• HEADWAY MC172150SX-AL

  Catheter, percutaneous
  3 reports
• Headway MC212156S

  CATHETER, PERCUTANEOUS
  2 reports
• HEADWAY MC17215045X-AL

  Catheter, percutaneous
  2 reports
• HEADWAY MC17215090X-AL

  Catheter, percutaneous
  1 report
• HEADWAY MC172150JX-AL

  Catheter, percutaneous
  1 report

Recent HEADWAY adverse event reports

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

• MalfunctionSep 23, 2026Break

  It was reported that when the microcatheter Headway-17 was opened the device was straight, but when the microguide was advanced by 0.014 mm, the doctor realized it wasn't progressing. He tried repeatedly, but it was never possible. The device was inspected and found to be fractured in the proximal portion. Another device is used to resolve the case. The patient is in good clinical condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872020 ↗
• MalfunctionSep 16, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793097 ↗
• MalfunctionSep 11, 2026Material Protrusion/Extrusion

  As reported: Stent would not advance through Headway 27 catheter. Stent deployed in catheter hub. A new Headway 27 and stent were required.Type of Surgery being performed and Treatment Site: Aneurysm embolization with flow diverting stent.When the device was received for evaluation, the investigation findings found an exposed coil/braid protruding into the lumen at the hub transition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727673 ↗
• MalfunctionMay 22, 2026Material Protrusion/Extrusion

  EVENT DESCRIPTION: VIA AN EMAIL FROM THE HOSPITAL (TRANSLATION DONE VIA DEEPL) AS REPORTED TO MICROVENTION: ¿A 48-YEAR-OLD FEMALE PATIENT WAS HOSPITALIZED FOR EMBOLIZATION OF A GIANT BASILAR ARTERY ANEURYSM USING A FLOW DIVERTER. DURING THE PROCEDURE, THE OPERATOR ENCOUNTERED A PROBLEM INSERTING THE EMBOTRAP III THROMBECTOMY DEVICE INTO A HEADWAY 21 MICROCATHETER: IT WAS IMPOSSIBLE TO PASS THE DEVICE THROUGH THE CONICAL SECTION OF THE MICROCATHETER. THE EMBOTRAP RETRIEVER DEVICE WAS DAMAGED AND UNUSABLE. ANOTHER DEVICE WAS USED. CATHETER IS AVAILABLE FOR RETURN . NO REPORTED PATIENT IMPACT OR INJURY.¿ CLARIFICATION RECEIVED FROM THE MICROVENTION SALES REP ON THE COMPLAINT FORM INDICATES : ¿48YO PATIENT CAME FOR A GIANT ANEURISM EMBOLIZATION OF THE BASILAR TRONC WITH FLOW DIVERTER SILK 4.5X20 FROM BALT COMPANY. DURING THE PROCEDURE IT WAS IMPOSSIBLE TO PUT THE FLOW DIVERTER SILK VISTA BABY 4.5X20MM INTO THE HUB OF THE HEADWAY21. A SMALL PIECE OF THE DISTAL PUSHER BROKE INTO THE HEADWAY21 DURING THE INTRODUCTION OF THE SILK. THE PHYSICIAN TRIED TO PULL THE PIECE OF THE PUSHER WITH AN EMBOCATCH NIMBUS FROM DUOMED COMPANY WITHOUT SUCCESS. MULTIPLE ATTEMPTS AT RETRIEVAL USING EMBOCATCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263093 ↗
• MalfunctionMay 1, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING PREPARATION FOR A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, DURING STENT PROGRESSION, RESISTANCE WAS OBSERVED IN THE DEVICE AS IT PASSED THROUGH THE MICROCATHETER. AFTER REINSERTION OF THE DEVICE INTO ITS INTRODUCER SHEATH, THE STENT SPONTANEOUSLY RELEASED ITSELF FROM THE MICROCATHETER HUB. THE PRODUCTS WERE REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED AN EXPOSED BRAID PROTRUDING INTO THE LUMEN AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059625 ↗
• 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 31, 2026Material Protrusion/Extrusion

  AS REPORTED, IMPOSSIBLE TO INTRODUCE THE WEB IN 3 MICROCATHETERS: (X2) VIA 17 AND (X1) HEADWAY 17, LOT: 000993008. THE PHYSICIAN FINALLY DECIDED TO USE AN ARTISSE. THERE WAS NO REPORT OF INJURY. NO CONSEQUENCE FOR THE PATIENT. WHEN THE DEVICE, HEADWAY 17 MICROCATHETER WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS REVEALED AN EXPOSED LUMEN COIL PROTRUDING INTO THE CATHETER LUMEN. THEREFORE, A REPORT IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748663 ↗
• 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 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS WAS AN EMBOLIZATION PROCEDURE FOR A LARGE UNRUPTURED LEFT CAROTID-OPHTHALMIC ANEURYSM. THERE WERE TWO SUCCESSIVE ATTEMPTS TO DEPLOY TWO SILK 4.75X20MM FLOW DIVERTER STENTS, BUT THESE DID NOT OPEN PROPERLY IN THE DISTAL SECTION AND COULD NOT BE RECAPTURED BY THE MICROCATHETER. A SECOND FLOW DIVERTER STENT (FROM ANOTHER MANUFACTURER) WAS THEN DEPLOYED, THIS TIME WITH GOOD STENT PLACEMENT. CURRENT PATIENT STATUS: CLASSIFIED AS C DUE TO SIGNIFICANT INCREASE IN PROCEDURE DURATION: APPROXIMATELY 1 HOUR ABOVE AVERAGE. NO CONSEQUENCES FOR THE PATIENT, PATIENT MONITORED, DISCHARGED FROM HOSPITAL WITH NO POST-OPERATIVE CONSEQUENCES DETECTED. ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: MONITORING. THE REPORT IS BEING SUBMITTED BASED ON THE INCREASED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531489 ↗
• MalfunctionMar 5, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, THE FRED STENT DEVICE INITIALLY PROVED RESISTANT TO MICROCATHETER INSERTION (ONLY THE TIP COIL PENETRATED); SO, THE DEVICE WAS REPLACED WITH ANOTHER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 24523632 ↗
• MalfunctionFeb 19, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER. THE MICROCATHETER AND COIL WERE BOTH REMOVED FROM THE PATIENT WITHOUT ANY ADVERSE EVENTS. THERE WAS NO PATIENT INJURY. 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 24396990 ↗
• 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 ↗
• MalfunctionFeb 10, 2026Material Protrusion/Extrusion

  IT WAS REPORTED WHEN TREATING A ACI ANEURYSM, A FREDX SHOULD BE USED. THE XFRED COULD NOT BE COMPLETELY PUSHED THROUGH THE HEADWAY21. UPON CLOSER INSPECTION, IT WAS NOTICED THAT THERE WAS A FOREIGN OBJECT ON THE PUSHER WIRE. TO SUCCESSFULLY FINISH THE INTERVENTION, ANOTHER HEADWAY21 WITH THE SAME AND ANOTHER XFRED2513 WERE TAKEN. NO INJURY TO THE PATIENT. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED BRAID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310020 ↗
• MalfunctionJan 30, 2026Material Protrusion/Extrusion

  IT WAS INITIALLY REPORTED THAT THE MICROWIRE COULD NOT BE INSERTED INTO THE CATHETER HUB. A NEW HEADWAY PRODUCT WAS USED INSTEAD. THE PATIENT WAS REPORTED TO BE STABLE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED AN EXPOSED COIL PROTRUDING INTO THE LUMEN AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228538 ↗

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