EMBOLD™ Fibered M001394240140500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729983712), received between Jun 18, 2024 and Apr 22, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Stretched” (3 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.

• InjuryApr 22, 2026Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL WAS SURGICALLY REMOVED. A 14X50 EMBOLD? FIBERED DEVICE WAS UTILIZED FOR AN EMBOLIZATION PROCEDURE ON A MODERATELY TORTUOUS SUBCLAVIAN ARTERY WITH A TARGET VESSEL DIAMETER OF APPROXIMATELY 10MM. THIS EMBOLD COIL WAS USED FOR THE FIRST EMBOLIZATION AND WAS BELIEVED TO HAVE BEEN DEPLOYED. SUBSEQUENTLY, ANOTHER EMBOLD COIL AND A PACKING COIL WERE INSERTED. IT WAS THEN NOTICED THAT THE FIRST EMBOLD COIL HAD UNRAVELED OR STRETCHED AT ITS MIDPOINT AND WAS STICKING OUT FROM THE MICROCATHETER. IT WAS SUSPECTED THAT THE COIL MAY HAVE BEEN PULLED INTO THE MICROCATHETER BEFORE IT HAD FULLY DETACHED. SINCE PLACEMENT INSIDE THE BODY WAS NO LONGER POSSIBLE, ALL COILS WERE REMOVED SURGICALLY VIA INCISION OF THE SUBCLAVIAN ARTERY, AND THE PROCEDURE WAS DISCONTINUED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955478 ↗
• InjuryMar 24, 2026Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device

  IT WAS REPORTED THAT THE COIL MIGRATED, AND ADDITIONAL INTERVENTION WAS REQUIRED. AN EMBOLD FIBERED 14X50 WAS SELECTED FOR USE IN AN OVARIAN VEIN EMBOLIZATION TO TREAT PELVIC CONGESTION. THE TARGET LESION WAS MILDLY CALCIFIED AND TORTUOUS. THE COIL WAS USED ALONG WITH A 2.8 NON-BOSTON SCIENTIFIC MICROCATHETER. PRIOR TO USE OF THIS COIL, A 12X30 COIL WAS DEPLOYED WITH NO ISSUES. THE RESIDENT BEGAN DEPLOYING THE COMPLAINT DEVICE UNTIL RESISTANCE WAS MET, THEN WAS UNABLE TO ADVANCE AT LEAST 30 CM OF COIL OUT OF THE MICROCATHETER. THE MICROCATHETER WAS PULLED BACK, AND THE PHYSICIAN ATTEMPTED TO GIVE THE COIL MORE SPACE TO DEPLOY, BUT DEPLOYMENT WAS UNSUCCESSFUL. AT THIS TIME, THE RESIDENT BEGAN TO RETRACT THE COIL, AND THE COIL WOULD NOT MOVE. THE RESIDENT ENDED UP RETRACTING BOTH THE MICROCATHETER AND THE COIL, WHICH WAS PROTRUDING FROM THE TIP OF THE MICROCATHETER. THE COIL THEN MIGRATED HIGHER UP AND DEPLOYED WHILE TRYING TO REMOVE THE MICROCATHETER. THE RESIDENT USED A SNARE TO RETRIEVE THE COIL, A PROCESS WHICH TOOK 3.5 HOURS. IN THE END, THE PROCEDURE WAS ABORTED WITHOUT IMPLANTING AN ADDITIONAL COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674471 ↗
• InjuryJun 18, 2024Premature Activation; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Premature Activation; Stretched; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PROXIMAL END OF THE COIL PROTRUDED TO A NON-TARGET VESSEL CAUSING NON-TARGETED EMBOLIZATION, REQUIRING AN ATTEMPTED SNARING OF THE DEVICE, AND HOSPITALIZATION. THIS 14X50 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN AN ENDOLEAK EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL BECAME DIFFICULT TO ADVANCE APPROXIMATELY 30CM INTO THE DISTAL PART OF THE MICROCATHETER. IT WAS RETRACTED AND IT WAS BELIEVED THAT THE COIL BECAME DETACHED AT THE COUPLER, STRETCHING APPROXIMATELY 100CM AND BECOMING ENTANGLED. THE MICROCATHETER WAS REMOVED AND THE DISTAL END OF THE COIL REMAINED IN THE TARGETED VESSEL; HOWEVER, THE PROXIMAL END PROTRUDED INTO THE BRANCHES OF THE SUPERIOR MESENTERIC ARTERY (SMA), CAUSING NON-TARGET EMBOLIZATION. IT WAS NOTED THE TARGET VESSEL WAS MODERATELY TORTUOUS. AN ATTEMPT HAD BEEN MADE TO SNARE THE COIL WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THE ENDOLEAK SAC WAS SUCCESSFULLY EMBOLIZED.

  Patient problems: Embolism/Embolus

  MAUDE report 19562971 ↗