EMBOLD™ Fibered M001394240220600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729983743), received between Sep 18, 2023 and Jun 26, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Break; Difficult to Remove; Stretched; Failure to Advance; Material Protrusion/Extrusion; Break; Difficult to Remove; Stretched; Failure to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL BECAME STUCK AND HAD TO BE SNARED. A 22MM X 60CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF AN ANEURYSM DIRECTLY OFF OF THE AORTA. IT HAD PREVIOUSLY BEEN EMBOLIZED WITH A NUMBER OF COILS APPROXIMATELY A MONTH PRIOR, BUT IT WAS CONTINUING TO GROW. A 5F NON-BOSTON SCIENTIFIC (BSC) ANGIOGRAPHIC CATHETER AND A 2.3F NON-BSC MICROCATHETER WERE USED FOR ACCESS. INTERMITTENT FLUSH WAS PERFORMED. FOUR 32MM X 60CM EMBOLD FIBERED COILS WERE DEPLOYED SUCCESSFULLY. NEXT, AN ATTEMPT WAS MADE TO DEPLOY THIS 22MM X 60CM EMBOLD FIBERED COIL. PART OF THE COIL BEGAN TO COIL IN THE PACK AS EXPECTED, BUT RESISTANCE WAS MET WHEN THERE WAS ABOUT 10CM OF THE COIL LEFT INSIDE THE MICROCATHETER. THE COIL COULD NO LONGER BE ADVANCED OR RETRACTED. IT WAS UNKNOWN IF THE COIL WAS STUCK IN THE COIL PACK OR IN THE CATHETER. AN ATTEMPT WAS MADE TO TAKE OUT THE MICROCATHETER SYSTEM, BUT THE DISTAL PORTION OF THE COIL REMAINED IN THE COIL PACK WHILE THE REST OF THE COIL CONTINUED TO UNRAVEL ALL THE WAY OUT OF THE 5F CATHETER. THE PHYSICIAN SUCCESSFULLY FLUSHED THE INTACT COIL INTO THE PACK, BUT THE UNRAVELED PORTION REMAINED IN THE 5F CATHETER. THE PHYSICIAN TRIED P

  Patient problems: Foreign Body In Patient

  MAUDE report 22340536 ↗
• InjuryOct 2, 2024Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE COIL BECAME STUCK TO THE CATHETER TIP, AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE COIL. A 22 X 60 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ANEURYSM. AN 021 STRAIGHT MICROCATHETER WAS USED TO GAIN ACCESS TO THE SPLENIC ANEURYSM. UPON INSERTING THE COIL, THE COIL STARTED FLAILING AROUND THE ANEURYSM SAC. THE PHYSICIAN WENT TO RE-SHEATH THE COIL AND EXCHANGE IT FOR A SMALLER SIZE WHEN THE COIL STRETCHED AND CAUGHT ON THE MICROCATHETER TIP. RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT AND WITHDRAWAL. ULTIMATELY THE PHYSICIAN WENT IN THROUGH GROIN ACCESS WITH A SNARE TO REMOVE THE COIL FROM THE PATIENT'S BODY. PROCEDURE TIME WAS PROLONGED, BUT THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353830 ↗
• MalfunctionNov 9, 2023Difficult to Remove; Stretched; Material Protrusion/Extrusion; Difficult to Remove; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LOCATION. A 22MM X 60CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF A TYPE II ENDOLEAK ANEURYSM COMING OFF OF THE INFERIOR MESENTERIC ARTERY (IMA). THIS WAS THE FINAL COIL TO BE PLACED INSIDE THE ANEURYSM SAC. THE COIL WAS ADVANCED THROUGH THE INTRODUCER AND MICROCATHETER. THE DELIVERY WIRE WAS RETRACTED IN ORDER TO REPOSITION THE COIL, WHICH WAS STARTING TO MOVE INTO THE POINT OF ORIGIN. UPON RETRACTING, RESISTANCE WAS FELT WHILE PULLING. AFTER REVIEWING THE IMAGING, THE COIL APPEARED TO BE STRETCHED OUT BUT STILL INSIDE THE MICROCATHETER. THE MICROCATHETER WAS FLUSHED AND A 0.035-INCH WIRE WAS USED IN ORDER TO PUSH THE COIL THROUGH THE MICROCATHETER. THE COIL WAS IMPLANTED WITH APPROXIMATELY 20 CM OF THE STRETCHED PORTION OF THE COIL REMAINING INSIDE THE IMA BUT OUTSIDE THE ANEURYSM SAC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT TORTUOSITY WAS MILD. WHEN REVIEWING THE IMAGING, THE COIL APPEARED TO BE STRETCHED WITH THE COIL STILL INSIDE THE MICROCATHETER AND ONLY A PART OF THE COIL WAS OUT OF THE MICROCATHETER. HOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105313 ↗
• InjurySep 18, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Break; Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WAS AN UNRETRIEVED DEVICE FRAGMENT. A 22X60 EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ARTERY PSEUDOANEURYSM. THE ANATOMY WAS MODERATELY TORTUOUS. THE COIL WAS ADVANCED THROUGH A 2.4FR NON-BOSTON SCIENTIFIC MICROCATHETER. WHILE POSITIONING THE COIL INTO THE PSEUDOANEURYSM, THERE WERE QUITE A FEW TURNS, AND THE COIL WAS NOT ADVANCING SMOOTHLY AND BEGAN BUCKLING. THE PHYSICIAN THEN TRIED TO PULL THE COIL BACK OUT, BUT IT SEPARATED. UNDER FLUOROSCOPY, A "LONG STRING OF SOMETHING, SOME KIND OF WIRE, FIBER THING" WAS OBSERVED THAT WENT ALL THE WAY DOWN TO THE GROIN. THE COIL WAS SNARED, BUT WHILE DOING SO, ONE WHOLE PIECE BROKE OFF. MOST OF THE DEVICE WAS RETRIEVED, BUT THERE WAS STILL A PIECE THAT GOES FROM THE PSEUDOANEURYSM THROUGH THE SPLENIC ARTERY OUT INTO THE CELIAC AND ABOUT 5CM OUT INTO THE ABDOMINAL AORTA. THE PHYSICIAN DID NOT THINK THIS WILL CAUSE AN ISSUE AS IT WAS NOT FLOW-LIMITING OR CAUSING ANY OBSTRUCTION. FLOW WAS STILL GOOD. THE RADIOPAQUE PART OF THE COIL WAS MOSTLY IN THE SPLENIC ARTERY, AND THERE'S A LESS RADIOPAQUE PART THAT IS VERY THIN AND SOFT WHICH HANGS OUT INTO THE CELIAC/AORTA. APPROXIMATELY 20-30CM

  Patient problems: Foreign Body In Patient

  MAUDE report 17769516 ↗