EMBOLD™ Fibered M001394240100200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729983637), received between Mar 5, 2025 and Jul 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Premature Activation; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUN2026. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10X20 EMBOLD FIBERED WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. THE COIL WAS DIFFICULT TO ADVANCE AND DEPLOYED IN THE CATHETER BEFORE 25 PERCENT OF THE COIL WAS DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED COIL SEPARATION FROM THE DISTAL COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738424 ↗
• MalfunctionFeb 26, 2026Stretched; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE DEVICE WAS PROTRUDING FROM THE TARGET LOCATION. THIS 10X20 EMBOLD? FIBERED DEVICE WAS SELECTED FOR USE DURING A SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL DID NOT DETACH FROM THE DELIVERY WIRE WHEN THE PROXIMAL RELEASE MECHANISM WAS ACTIVATED. THE COIL WAS AT THE TARGET LOCATION WITH A PIECE OF THE COIL THAT DID NOT FULLY DETACH. WHEN THE SYSTEM WAS BEING PULLED BACK, THE COIL PULLED BACK WITH IT. WITH TIME AND MANEUVERING THEY WERE ABLE TO DETACH THE COIL ENOUGH WHERE ONLY A SHORT PIECE WAS LEFT DANGLING. IT WAS ADDITIONALLY NOTED THAT THE COIL BECAME STRETCHED AS A RESULT OF THIS. A ROAD RUNNER GUIDEWIRE AND ENVOY GUIDEWIRE WERE USED TO BREAK THE FILAMENT/TETHER STRING FROM THE DISTAL END OF THE COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462584 ↗
• MalfunctionMar 5, 2025Stretched; Difficult to Advance; Material Protrusion/Extrusion; Stretched; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL STRETCHED AND WAS PROTRUDING FROM THE TARGET LOCATION. TWO 10X20 EMBOLD FIBERED DEVICES WERE SELECTED FOR USE FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, UPON ADVANCING ONE OF THE COILS FORWARD THROUGH THE MICROCATHETER, THE COILS NORMAL RESISTANCE WHEN PUSHING FORWARD DISAPPEARED. IT APPEARED VIA IMAGING THAT THE COIL STRETCHED, AND THE COUPLER COULD BE SEEN AS WELL AS A LONG AREA OF STRETCHED COIL EXTENDING INTO AN AREA THEY DID NOT INTEND TO COIL. BOTH COILS REMAIN IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527508 ↗