HEADWAY MC212156S-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842429117484), received between Feb 22, 2025 and May 22, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 17, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: USED A HEADWAY21 AND ATTEMPTED TO DELIVER A COMPETITOR FLOW DIVERTER WITH IT, BUT UNFORTUNATELY IT DIDN¿T WORK. ACCORDING TO BOTH PACKAGES, THEY SHOULD HAVE BEEN COMPATIBLE. THE COMPETITOR FLOW DIVERTER COULD NOT BE PUSHED THROUGH THE HEADWAY21. THE PHYSICIAN NOTICED STRONG FRICTION WHEN PUSHING IT FORWARD. FOR CASE COMPLETION, THEY USED A DIFFERENT MICROCATHETER TO IMPLANT THE COMPETITOR FLOW DIVERTER, AND THIS WENT SMOOTHLY WITHOUT ANY COMPLICATIONS. PATIENT IS DOING FINE! WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED BRAID AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825610 ↗
• MalfunctionNov 13, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: SYNCHRO 14 WIRE WOULD NOT FIT THROUGH THE HEADWAY 21. THE HEADWAY 21 WAS FLUSHED AND THE SYNCHRO WIRE WAS LUBRICATED TO INSURE PROPER FIT. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THE DEVICE IS AVAILABLE FOR EVALUATION. THE PRODUCT INVESTIGATION FOUND EXPOSED LUMEN COIL PROTRUDING INTO THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548051 ↗
• MalfunctionJul 24, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  A NON-REPORTABLE REPORT IS BEING SUBMITTED BASED ON THE RETURNED PRODUCT INVESTIGATION FINDINGS. THE PTFE LINING OF THE MICROCATHETER LUMEN WAS FOUND TO BE INTACT AND NO DAMAGE WAS OBSERVED TO THE MICROCATHETER COATING. BASED ON THE INVESTIGATION FINDINGS, THIS EVENT NO LONGER MEETS THE MDR REPORTABLE CRITERIA. ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATED WHEN THE ADVANCEMENT DIFFICULTY WITH THE GUIDEWIRE WAS ENCOUNTERED, IT WAS SUSPECTED THAT THE COATING MAY HAVE DETACHED. HOWEVER, THIS WAS INDICATED TO BE AN ASSUMPTION, THE CAUSE OF THE ADVANCEMENT DIFFICULTLY WAS NOT KNOWN. PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586622 ↗
• InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MICROCATHETER WAS BEING USED WITH A FLOW DIVERTER STENT IN UNSPECIFIED EMBOLIZATION PROCEDURE. REPORTEDLY, THERE WAS RESISTANCE AT THE HUB OF THE MICROCATHETER THAT DAMAGED 2 FLOW DIVERTER STENTS THAT WERE ATTEMPTED TO BE ADVANCED IN THE MICROCATHETER. THE PHYSICIAN COULD NOT CHANGE THE MICROCATHETER AS NAVIGATION WAS VERY DIFFICULT AND FINALLY MANAGED TO OPEN THE HUB OF THE MICROCATHETER BY INTRODUCING THE PROXIMAL END OF A 0.14 GUIDEWIRE. A NEW FLOW DIVERTER STENT WAS THEN ADVANCE AND IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE PROCEDURE TIME WAS EXTENDED BY 30 MINUTES DUE TO THIS PROBLEM. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485914 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE SEE CORRECTION TO SECTION B1, B2, AND H1 FROM MALFUNCTION TO SERIOUS INJURY FOR THE DELAY IN THE PROCEDURE. PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21441863 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE SEE CORRECTION TO SECTION B1, B2, AND H1 FROM MALFUNCTION TO SERIOUS INJURY FOR THE DELAY IN THE PROCEDURE. PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21441851 ↗