EMBOLD™ Fibered M001394240120200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729983668), received between Jul 25, 2024 and Sep 1, 2026 — classified as 2 injuries.

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

• InjurySep 1, 2026Entrapment of Device; Difficult to Remove; Stretched

  It was reported that the coil stretched, requiring additional intervention.An EMBOLD¿ Fibered 12x20 device was selected to treat variceal bleeding in the portal branches. The target lesion was reported as moderately tortuous. The coil was successfully placed in the target vessel proximal to several other Embold Fibered Coils and non-Boston Scientific packing coils. After breaking the proximal release perforation, the physician proceeded to withdraw the pull wire. Under fluoroscopy, the physician noted that the coil appeared to be withdrawing along with the pull wire. The physician noted that the pull wire appeared to be stuck to the catheter tip and reported resistance when attempting to withdraw. A snare was used to remove the pull wire. The coil was noted to be stretched within the vessel. Several other coils were then successfully deployed proximal to the stretched coil. There were no patient consequences as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547920 ↗
• InjuryJul 25, 2024Stretched; Separation Failure; Material Protrusion/Extrusion; Difficult or Delayed Separation; Stretched; Separation Failure; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LOCATION REQUIRING ADDITIONAL INTERVENTION. AN EMBOLD FIBERED 12X20 COIL WAS SELECTED FOR USE TO TREAT A 12MM ANEURYSM LOCATED IN A NON-TORTUOUS LEFT RENAL ARTERY. TWO EMBOLD COILS HAD ALREADY BEEN SUCCESSFULLY PLACED IN THE ANEURYSM. THE 12X20 EMBOLD COIL WAS ADVANCED WITHOUT DIFFICULTY AND POSITIONED IN THE ANEURYSM. THE COIL WAS READY TO BE DEPLOYED, HOWEVER, IT WOULD NOT DETACH. THE PHYSICIAN MANIPULATED THE PUSHER WIRE BACK AND FORTH AND THE COUPLER WAS OBSERVED PAST THE RO MARKER BAND OF THE RENEGADE STC CATHETER. THE COIL APPEARED TO BE DETACHED, AND THE PUSHER WIRE AND CATHETER WERE REMOVED WITHOUT ANY DIFFICULTY. AT THIS POINT, A STRETCHED EMBOLD COIL WAS SEEN IN THE MAIN BRANCH OF THE RENAL ARTERY, AND THE COUPLER WAS IN THE ABDOMINAL AORTA. A MULTI-LOOP SNARE WAS USED TO SUCCESSFULLY REMOVE THE COIL FULLY INTACT. A RENAL ANGIOGRAM WAS PERFORMED TO MAKE SURE THE RENAL ARTERY WAS NOT COMPROMISED FROM THE COIL BEING IN THE VESSEL DURING THE TIME IT TOOK TO SNARE THE COIL. THERE WERE NO PROBLEMS OBSERVED. THE PROCEDURE WAS COMPLETED WITH THE TWO COILS THAT HAD ALREADY BEEN IMPLANTED. THERE WERE NO PATIENT COMPLICAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828410 ↗