EMBOLD™ Fibered M001394240200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729983736), received between Oct 15, 2025 and Sep 24, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjurySep 24, 2026Device-Device Incompatibility; Material Protrusion/Extrusion

  It was reported that the previously deployed coil was pulled out of position, and intervention was required to correct its position.Two 20mm x 50cm EMBOLD? Fibered coils were selected for use in the embolization of a splenic artery aneurysm. Other non-Boston Scientific coils were also used in the procedure. The microcatheter was flushed immediately prior to coil insertion, and continuous flushing was performed throughout the procedure. During the procedure, resistance was felt during coil placement. An attempt was made to retrieve the coil; however, the coil became unraveled, making retrieval impossible. An attempt was made to withdraw the coil together with the microcatheter; however, the previously deployed coil, another 20mm x 50cm EMBOLD. Fibered coil, also moved. It might have been the coil that caught on the previously deployed coil. As a result, retrieval was unsuccessful. The unraveled coil was secured with a balloon and cut outside the body. The cut end was pushed into the aneurysm using another coil, resulting in a portion of the coil remaining in the body. The previously deployed coil moved out of position, partially in the target vessel and partially protruding out of t

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889517 ↗
• InjuryAug 27, 2026Difficult to Remove; Stretched; Failure to Advance; Device-Device Incompatibility

  It was reported that the stretched coil required intervention to retrieve, but there were unretrieved device fragments.A 20mm x 50cm EMBOLD Fibered coil was selected for use in the embolization of a splenic artery aneurysm. During the procedure, resistance was felt during coil placement. An attempt was made to retrieve the coil; however, the coil became unraveled, making retrieval impossible. An attempt was made to withdraw the coil together with the microcatheter; however, a previously deployed coil also moved. As a result, retrieval was unsuccessful. The unraveled coil was secured with a balloon and cut outside the body. The cut end was pushed into the aneurysm using another coil, resulting in a portion of the coil remaining in the body. There were no patient complications as a result of this event.

  Patient problems: Foreign Body In Patient

  MAUDE report 50478241 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16SEP2025. IT WAS REPORTED THAT THE PROXIMAL RELEASE WAS DIFFICULT TO BREAK. AN EMBOLD FIBERED 20X50 WAS SELECTED FOR A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE IN THE GASTRORENAL SHUNT. WHEN ATTEMPTING TO DEPLOY THE COIL, HOWEVER, THE PROXIMAL RELEASE COULD NOT BE DETACHED WHETHER IT WAS BENT OR PULLED. A NEW COIL OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL WAS SEPARATED AT THE COUPLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299999 ↗