HEADWAY MC272156S-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429117507), received between Jan 14, 2026 and Sep 11, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionJan 30, 2026Material Protrusion/Extrusion

  IT WAS INITIALLY REPORTED THAT THE LUER SAMPLE WAS UNUSED AND WAS REMOVED FROM THE PACKAGING. THE LUER HUB WAS TRIMMED TO GET A CLOSER LOOK AT THE CATHETER INNER DIAMETER. WE COULDN¿T INSERT A PIN GAGE OF 0.026¿ MINUS; THE PIN GAUGE WAS MEASURED WITH A LASER MICROMETER, AND THE DIAMETER WAS AROUND 0.02592.¿ THE DIAMETER IN THIS CASE IS BELOW THE FINAL INSPECTION ACCEPTABLE DIAMETER. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED AN EXPOSED BRAID AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228509 ↗
• MalfunctionJan 30, 2026Material Protrusion/Extrusion

  IT WAS INITIALLY REPORTED THAT PROBLEMS WERE ENCOUNTERED INSERTING THE STENT DURING IN-HOUSE TESTING. THE STENT DOES NOT GO PAST THE LUER HUB DURING INSERTION. THE STENT¿S MARKER BAND AT THE PUSHER AREA IS THE WHERE THE STENT IS GETTING STUCK. A PIN GAUGE WAS INSERTED TO MEASURE THE CATHETER INNER DIAMETER AND DID NOT ALLOW A 0.026¿ TO GO THROUGH. AFTER LOOKING AT THE SAMPLES IN THE MICROSCOPE, THERE IS SOME LINER DELAMINATION, AND THE CATHETER END CAN BE SEEN. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED AN EXPOSED COIL PROTRUDING INTO THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228492 ↗
• MalfunctionJan 30, 2026Material Protrusion/Extrusion

  IT WAS INITIALLY REPORTED THAT DURING THE IN-HOUSE SIMULATED TESTING OF STENTS AT THE MANUFACTURING SITE, WE HAD ISSUES WITH HEADWAY 27 CATHETER. THE PUSHER MARKER BAND AREA OF THE STENT COULD NOT GO THROUGH THE CATHETER HUB INNER LUMEN. THE INNER LUMEN OF THE SECOND CATHETER WAS VERIFIED USING A PIN GAUGE AND CONFIRMED THE DIAMETER IS 0.026¿ (TIGHT FIT) WITH A 0.025¿ CATHETER MOVING FREELY. THE PROXIMAL ID NEEDS TO ALLOW FOR A PIN GAUGE OF 0.0280-0.0283¿ TO GO THROUGH. 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 24228434 ↗
• MalfunctionJan 14, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE ATTEMPT TO INTRODUCE THE STENT INTO THE MICROCATHETER, IT WAS VERIFIED THAT THE DELIVERY SYSTEM ADVANCED, BUT THE STENT GOT STUCK AT THE ENTRANCE OF THE MICROCATHETER, DAMAGING THE MESH AND OBSTRUCTING THE MICROCATHETER. THE DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS GREAT. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, IT WAS FOUND THAT THE CATHETER SHAFT EXHIBITED INCOMPLETE FLARING WITH EXPOSED BRAID AT THE HUB TRANSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069403 ↗