EMBOLD™ Fibered M001394240040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729983569), received between Jun 8, 2023 and Sep 1, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551531 ↗
• MalfunctionMar 24, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24FEB2025. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. A 4X8 EMBOLD FIBERED WAS SELECTED FOR AN EMBOLIZATION PROCEDURE TO TREAT A PANCREATIC ANEURYSM. THE 4X8 COIL WAS ADVANCED; HOWEVER, THE PHYSICIAN DECIDED ON USING A SMALLER COIL FIRST. THE 4X8 COIL WAS REMOVED FROM THE PATIENT AND RE-HOUSED IN THE LOOP IN SALINE. THE COIL WAS PULLED OUT OF THE HOOP FOR LATER USE, BUT IT WOULD NOT ADVANCE THROUGH THE MICROCATHETER. A TOTAL OF 17 EMBOLD COILS WERE USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677853 ↗
• InjuryNov 20, 2023Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COILS WERE PROTRUDING FROM THE TARGET LOCATION, AND THERE WAS AN UNSUCCESSFUL SNARE ATTEMPT. THIS 4X8 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, TWO NON-BOSTON SCIENTIFIC COILS WERE USED, THEN THE PHYSICIAN WANTED A SMALLER COIL. THEREFORE, THIS EMBOLD COIL WAS USED AND AFTER PACKING, IT WAS PROTRUDING FROM THE TARGET LOCATION. IT WAS THEREFORE RETRACTED ONCE AND THEN PUSHED BACK IN; HOWEVER, IT BECAME STRETCHED. ADDITIONALLY, ISSUES OF DIFFICULT TO RETRACT/REMOVE AND DIFFICULT TO ADVANCE THROUGH THE GUIDE CATHETER WERE ALSO REPORTED. AN ATTEMPT WAS MADE TO RESHEATH THE COIL BUT WAS NOT SUCCESSFUL. ADDITIONALLY, AN ATTEMPT WAS MADE TO SNARE THE COIL; HOWEVER, BECAUSE THE COIL WAS SO STRETCHED THE FILAMENT MADE IT DIFFICULT TO SNARE, AND IT WAS LEFT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172947 ↗
• MalfunctionOct 26, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL FRACTURED INTERNALLY, AND ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE A PORTION OF THE COIL. AN EMBOLD FIBERED 4X8 WAS SELECTED FOR USE FOR AN EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA). THE COIL WAS DIFFICULT TO RETRACT INTO THE MICROCATHETER AND STRETCHED AS A RESULT. THE COIL FRACTURED, AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE COIL. A PORTION OF THE FRACTURED COIL REMAINED IMPLANTED IN THE PATIENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER, AND THE EMBOLIZATION PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED. IT WAS FURTHER REPORTED THAT THE TARGET ANEURYSM WAS ACCESSED USING A .016 FATHOM GUIDEWIRE AND AN UNKNOWN .021 STC MICROCATHETER. THE MICROCATHETER WAS FLUSHED WITH SALINE, AND THERE WERE NO ISSUES LOADING THE COIL INTO THE MICROCATHETER. AS THE COIL WAS ADVANCING WITHIN APPROXIMATELY THE LAST 20 CM OF THE MICROCATHETER, THERE WAS INCREASING RESISTANCE AND FRICTION. THE PHYSICIAN ELECTED TO REMOVE THE COIL FROM THE MICROCATHETER AND OBSERVED THAT THE COIL HAD BECOME UNRAVELED. THERE WAS A LONG, THIN, NON-RADIOPAQUE FILAMENT WITHIN THE CATHETER. THE ENTIRE MICROCATHETER WAS REMOVED AND REPLACED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012245 ↗
• InjuryJun 8, 2023Break; Difficult to Remove; Stretched; Malposition of Device; Material Integrity Problem; Break; Difficult to Remove; Stretched; Malposition of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL BROKE AND WAS LEFT IN A NON-TARGET LOCATION. A 4X8 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION PROCEDURE TO TREAT A GI BLEED. THE TARGET VESSEL WAS NOT EXTREMELY TORTUOUS, BUT THERE WERE BRANCHES COMING OFF THE GDA ON THE PROXIMAL END THAT NEEDED TO BE EMBOLIZED AS WELL. THESE BRANCHES WERE SMALL AND AT A HARD ANGLE MAKING IT DIFFICULT TO CANNULATE. THEY WERE EVENTUALLY EMBOLIZED, BUT THERE WAS SOME SPASMING IN THE MAIN GDA AFTER MULTIPLE ATTEMPTS TO GET INTO THESE SMALL VESSELS. THIS COIL WAS BEING PLACED IN THE PROXIMAL ARTERY BUT NOT FORMING CORRECTLY. AFTER MULTIPLE ATTEMPTS, THE DISTAL END OF THE COIL HOOKED INTO A BRANCH AND ANOTHER ATTEMPT WAS MADE TO FORM IN THE MAIN ARTERY. COIL RETRACTION WAS ATTEMPTED, BUT THE COIL STRETCHED AND BROKE. A 6F SNARE WAS USED TO ATTEMPT TO SNARE THE STRETCHED COIL. IT WAS ALSO ATTEMPTED TO PUSH THE COIL WITH A PUSHER WIRE. AFTER THE FAILED ATTEMPTS TO RETRIEVE THE STRETCHED COIL, THE PROCEDURE WAS COMPLETED. THE STRETCHED COIL REMAINED IN A NON-TARGET LOCATION. THE COIL STARTED IN THE SMALL BRANCH OFF THE GDA AND WAS STRETCHED THROUGH THE COMMON HEPATI

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 17086529 ↗