EMBOLD™ Fibered M001394240050150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729983590), received between Jun 7, 2024 and Apr 28, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED IN THE CATHETER. A 5X15 EMBOLD FIBERED WAS SELECTED FOR USE IN AN INFERIOR MESENTERIC ARTERY EMBOLIZATION PROCEDURE. THE TARGET LOCATION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE COIL DETACHED EARLY INSIDE THE MIDDLE PART OF THE NON-BOSTON SCIENTIFIC CATHETER. THE INNER DIAMETER OF THE CATHETER WAS 0.022 INCHES. THE ENTIRE CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A COIL DETACHED FROM THE DISTAL COUPLER WHILE THE COUPLER REMAINS ATTACHED TO THE PROXIMAL COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017802 ↗
• MalfunctionApr 8, 2026Entrapment of Device; Difficult to Remove; Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. AN EMBOLD? FIBERED WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE TO TREAT A BLEED IN AN ANEURYSM. DURING THE PROCEDURE, AFTER A COUPLE OF LOOPS WERE FORMED WITHIN THE VESSEL, THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE COIL WITHIN THE NON-BOSTON SCIENTIFIC MICROCATHETER. THE COIL WAS RETRACTED BACK, BUT RESISTANCE WAS AGAIN ENCOUNTERED. THE COUPLE OF LOOPS THAT HAD FORMED WITHIN THE VESSEL WERE NOT RETRACTING BACK INTO THE MICROCATHETER, SO THE MICROCATHETER AND COIL WERE REMOVED AS A UNIT. A PORTION OF THE COIL WAS PROTRUDING FROM THE TIP OF THE MICROCATHETER DURING WITHDRAWAL, AND THE COIL WAS STRETCHED. ANOTHER COIL WAS USED IN THE MICROCATHETER WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH THE ALTERNATE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL BROKE FROM THE DISTAL COUPLER WHILE THE COUPLERS WERE STILL CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820343 ↗
• InjuryFeb 26, 2026Premature Activation; Malposition of Device; Material Protrusion/Extrusion

  IT WAS REPORTED IN A MEDWATCH REPORT THAT PREMATURE DEPLOYMENT IN AN UNINTENDED LOCATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. A 5X15 EMBOLD FIBERED WAS SELECTED FOR USE IN A Y90 EMBOLIZATION PROCEDURE TO TREAT LIVER CANCER. THE EMBOLD FIBERED COIL PREMATURELY DEPLOYED INTO AN UNINTENDED LOCATION, DURING REPOSITIONING OF THE COIL. THE EMBOLD FIBERED COIL PROTRUDED FROM THE INTENDED TARGET LOCATED AFTER DEPLOYMENT. TWO DIFFERENT SNARES WERE REQUIRED IN NUMEROUS ATTEMPTS TO REMOVE THE ENTIRE COIL FROM THE PATIENT, WHICH EXTENDED THE PROCEDURE TIME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457841 ↗
• InjuryDec 16, 2025Break; Premature Activation; Difficult to Remove; Failure to Advance; Break; Premature Activation; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED AND AN ADDITIONAL DEVICE WAS REQUIRED. THIS 5X15 EMBOLD? FIBERED DEVICE WAS SELECTED FOR USE DURING A CORONARY ARTERY FISTULA EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE EMBOLD DEVICE WAS INTRODUCED INTO THE MICROCATHETER. DURING THE DELIVERY PROCESS, THE DEVICE WAS UNABLE TO BE ADVANCED WHEN ONE THIRD OF THE COIL REMAINED, PREVENTING FURTHER PROGRESSION. UPON WITHDRAWING THE COIL, IT WAS FOUND THAT THE COIL HAD BECOME DETACHED, AND THE COIL REMAINED IN THE MAIN CORONARY ARTERY. IT WAS REMOVED WITH A RETRIEVAL DEVICE, AND A NEURO COIL WAS USED TO EMBOLIZE AND COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE COIL WAS ABLE TO BE PASSED APPROXIMATELY TWO THIRDS THROUGH THE CATHETER BEFORE IT COULD NO LONGER ADVANCE, AND RESISTANCE WAS ALSO EXPERIENCED UPON WITHDRAWAL. THE DELIVERY WIRE BROKE NEAR THE DISTAL COUPLER, AND UPON REMOVAL, BOTH COUPLERS REMAINED ON THE DELIVERY WIRE. ATTEMPTS HAD BEEN MADE TO REMOVE THE DEVICE AND MICROCATHETER AS A WHOLE; HOWEVER, WHEN REMOVED, IT WAS FOUND THAT THE COIL WAS DETACHED AND REMAINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821000 ↗
• MalfunctionJul 28, 2025Break; Difficult to Remove; Stretched; Failure to Advance; Positioning Problem; Break; Difficult to Remove; Stretched; Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT THE COIL BROKE. A 5MM X 15CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A GASTROINTESTINAL BLEED WITH SPLENIC TAKEDOWN. THE VESSEL WAS SEVERELY TORTUOUS. INTERMITTENT FLUSHING WAS PERFORMED DURING THE PROCEDURE. WHEN ADVANCING THE COIL OUT OF THE 2.8F NON-BOSTON SCIENTIFIC MICROCATHETER, THE PHYSICIAN WASN'T ABLE TO KEEP PUSHING AND ADVANCING THE COIL. AN ATTEMPT WAS MADE TO PULL THE COIL BACK IN AND THEN RE-ADVANCE, BUT THIS DID NOT HELP. EVENTUALLY, THE PHYSICIAN WENT TO PULL BACK AND REMOVE THE COIL, BUT THERE WAS RESISTANCE, AND IT STRETCHED UPON REMOVAL. THE RELEASE MECHANISM WAS NEVER USED. IT WAS BELIEVED THAT ALL OF THE COIL WAS REMOVED BECAUSE THE MICROCATHETER WAS ABLE TO BE FLUSHED WITH SALINE AND CONTRAST. HOWEVER, WHEN OBSIDIO WAS INJECTED IN THE MICROCATHETER, IT PUSHED A REMAINING SECTION OF STRETCHED COIL OUT INTO THE VESSEL TOGETHER WITH THE OBSIDIO MATERIAL. THE COIL FRAGMENT WAS IMPLANTED SOMEWHAT PROXIMAL BUT AROUND WHERE THEY WANTED TO EMBOLIZE. DUE TO CATHETER KICKBACK EXPERIENCED DURING OBSIDIO USE, THE MICROCATHETER WAS PULLED INTO THE BASE CATHETER, AND THE PROCEDURE WAS CONSIDERED COMPLETE. THERE WERE NO PATIENT CO

  Patient problems: Foreign Body In Patient

  MAUDE report 22635492 ↗
• MalfunctionJun 23, 2025Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAY2025. IT WAS REPORTED THAT A 5MM X 15CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A COMMON HEPATIC ARTERY ANEURYSM. DURING THE PROCEDURE, THE MICROCATHETER REACHED THE LESION SMOOTHLY WITH A GENTLE CURVE. AFTER CONNECTING THE EMBOLD DEVICE TO THE MICROCATHETER, THE INNER SHEATH OF THE EMBOLD WAS PUSHED OUT, BUT IT WAS VERY STIFF FROM THE START AND DID NOT SLIDE THROUGH THE OUTER SHEATH. INTERMITTENT FLUSHING WAS PERFORMED. THE COIL COULD NOT BE INSERTED INTO THE MICROCATHETER. THE COIL DID NOT EXIT THE INTRODUCER SHEATH AND WAS REMOVED AS IT WAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A COIL BREAK FROM THE COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310512 ↗
• MalfunctionMay 20, 2025Difficult to Remove; Stretched; Failure to Advance; Malposition of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device

  IT WAS REPORTED THAT THE COIL WAS MALPOSITIONED. AN EMBOLD FIBERED COIL WAS SELECTED FOR USE TO EMBOLIZE A BLEEDING GASTRODUODENAL ARTERY EMBOLIZATION (GDA). TWO 4MM COILS WERE SUCCESSFULLY PLACED, AND THEN A 5X15 EMBOLD FIBERED COIL WAS SELECTED. THE EMBOLD WENT THROUGH THE COIL PACK AND INTO THE SIDE BRANCH, HOWEVER, THE PHYSICIAN DID NOT WANT TO EMBOLIZE THAT. AN ATTEMPT TO GENTLY PULL THE COIL BACK INTO THE NON-BSC CATHETER WAS MADE, BUT THE COIL WAS STUCK. THEREFORE, AN ATTEMPT WAS MADE TO DEPLOY THE COIL BUT IT COULD NOT BE DEPLOYED OUT OF THE MICROCATHETER. THE MICROCATHETER WAS REMOVED, BUT THE DISTAL END OF THE COIL REMAINED COILED UP IN THE SIDE BRANCH. THE REST OF THE COIL STRETCHED TO THE COMMON HEPATIC AND INTO THE CELIAC. THERE WAS A FILAMENT REMAINING IN THE AORTA. THE EMBOLD COIL WAS LEFT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT STATUS WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054843 ↗
• MalfunctionOct 3, 2024Premature Activation; Stretched; Premature Activation; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06SEP2024. IT WAS REPORTED THAT THE COIL DETACHED EARLY IN THE CATHETER. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. A 5X15 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR AN ENDOVASCULAR ANEURYSM REPAIR. THE COIL WAS ONCE ATTEMPTED TO BE PLACED; HOWEVER, IT WAS RECAPTURED INTO THE INTRODUCER SHEATH TO READJUST THE PLACEMENT SITE. THE COIL UNRAVELED INSIDE THE INTRODUCER SHEATH WHEN THE DELIVERY WIRE WAS PULLED DURING RECAPTURE, MAKING IT UNABLE TO BE USED. ANOTHER EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS STRETCHED AND DETACHED FROM THE DISTAL COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359474 ↗
• InjuryJun 7, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE COIL DID NOT PACK WELL ENOUGH AND WAS REMOVED USING A SNARE. THE EMBOLD FIBERED DETACHABLE COIL SYSTEM 5X15 WAS SELECTED FOR GASTROINTESTINAL BLEED EMBOLIZATION. THE PHYSICIAN DEPLOYED THE COIL OUTSIDE OF THE CATHETER; HOWEVER, AFTER DETACHING THE COIL IT WAS NOT PACKED WELL ENOUGH AND NEEDED TO BE REMOVED. THE PHYSICIAN USED A SNARE TO REMOVE THE COIL, AND ANOTHER PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484007 ↗