EMBOLD™ Fibered M001394240080200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729983620), received between Jan 27, 2023 and Apr 23, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL BROKE WITHIN THE MICROCATHETER. AN EMBOLD? FIBERED WAS SELECTED FOR USE DURING A SPLENIC ARTERY TO SPLENIC VEIN SHUNT COILING PROCEDURE. THE TARGET LESION WAS MODERATELY TORTUOUS. WHEN THE COIL WAS ADVANCED WITHIN THE MICROCATHETER, THE PHYSICIAN REPORTED THAT THE COIL FELT "GUMMY" ADVANCING. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL, BUT THE COIL BECAME STUCK IN THE MICROCATHETER AND BROKE. THE COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS FROM A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972543 ↗
• InjuryFeb 6, 2025Premature Activation; Stretched; Malposition of Device; Premature Activation; Stretched; Malposition of Device

  IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY AND MALPOSITIONED. AN 8MM X 20CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN INTERNAL MESENTERIC ARTERY ANEURYSM EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, INTERMITTENT FLUSHING WAS PERFORMED, AND A 021INCH NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED. THE PROXIMAL PART OF THE COIL BECAME DAMAGED INSIDE THE CATHETER. THE COIL UNRAVELED DURING MULTIPLE ATTEMPTS TO REPOSITION AT THE OSTIUM OF THE INTERNAL ILIAC ARTERY. FURTHERMORE, THE DETACHMENT POINT CAME OUT OF THE MICROCATHETER AT SOME POINT DURING REPOSITIONING, AND THE COIL DETACHED EARLY. THE COIL DETACHED IN AN UNINTENDED LOCATION. THE COIL WAS LEFT IN PLACE AS IS. HOWEVER, STENT PLACEMENT IS SCHEDULED TO BE PERFORMED AT A LATER DATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327815 ↗
• MalfunctionJan 30, 2025Premature Activation; Stretched; Material Protrusion/Extrusion; Premature Activation; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LOCATION. AN 8MM X 20CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A TYPE IB ENDOLEAK OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE EMBOLIZATION AREA WAS BETWEEN THE AORTIC WALL AND THE STENT GRAFT. THE ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE AAA SAC WAS PACKED WITH COILS. PRIOR TO THIS COIL, A NUMBER OF NON-BOSTON SCIENTIFIC COILS HAD BEEN DEPLOYED. THE EMBOLD FIBERED COIL WAS ADVANCED AS EXPECTED THROUGH A 1.5F NON-BOSTON SCIENTIFIC CATHETER. HOWEVER, WHEN ALMOST READY TO DEPLOY THE COIL, THE USER FELT SOMETHING BREAK. THEY WERE UNDER THE IMPRESSION THAT THE COIL HAD PREMATURELY DEPLOYED, SO THE DELIVERY WIRE WAS REMOVED. THE TECHNICIAN REPORTED INTENTIONALLY BREAKING THE DEPLOYMENT MECHANISM BUT COULD NOT RECALL AT EXACTLY WHAT MOMENT IT WAS BROKEN. THE COIL REMAINED IN PLACE, AND IT WAS THOUGHT THAT ALL WAS WELL. HOWEVER, AT CLOSE, A VERY THIN COIL-LIKE STRING WAS COMING OUT OF THE GROIN. THE COIL HAD STRETCHED ALL THE WAY TO THE GROIN. SCISSORS WERE USED TO CUT WHAT WAS OUTSIDE THE BODY, AND THE REST WAS LEFT IMPLANTED. THE COIL WAS LEFT PROTRUDING FROM THE TARGET LOCAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276995 ↗
• InjuryOct 9, 2024Stretched; Material Protrusion/Extrusion; Difficult or Delayed Separation; Stretched; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL STRETCHED AND PROTRUDED FROM THE TARGET LOCATION. AN 8MM X 20CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF A GASTROINTESTINAL BLEED IN THE GASTRODUODENAL ARTERY (GDA). EVERYTHING WENT SMOOTHLY WITH THE CASE UNTIL THIS LAST 8MM X 20CM COIL. THE MICROCATHETER WAS WITHIN THE COIL PACK DURING DEPLOYMENT, AND THE RELEASE OF THE DEPLOYMENT MECHANISM WAS UNEVENTFUL AS WELL. THE PHYSICIAN WAS PERFORMING FLUOROSCOPY WHILE RETRACTING AND DID NOT NOTICE ANY ISSUE UNTIL HE SAW THAT THE COLLARS OF THE DEPLOYMENT MECHANISM WITHIN THE MICROCATHETER SHAFT APPARENTLY NOT SEPARATED. HE ULTIMATELY ATTEMPTED TO SNARE THE MANDRIL, BUT THIS WAS UNSUCCESSFUL. HE ABANDONED MORE ATTEMPTS AS HE DIDN'T WANT TO POTENTIALLY DISLODGE THE PACKING COIL THAT WAS JUST DISTAL TO THIS STRETCHED COIL. THE STRETCHED COIL WAS LEFT IN PLACE AS THERE WASN'T A BETTER SOLUTION TO TRY AND RETRIEVE. THE PROCEDURE WAS COMPLETED. THE PATIENT DID OKAY. NO FURTHER ACTION WAS PLANNED; THEY WILL CONTINUE TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407659 ↗
• MalfunctionSep 9, 2024Break; Premature Activation; Stretched; Malposition of Device; Break; Premature Activation; Stretched; Malposition of Device

  IT WAS REPORTED THAT THE COIL MALPOSITIONED. AN 8MM X 20CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN AN ANEURYSM BLEED. THE PSEUDOANEURYSM WAS OFF THE COMMON HEPATIC ARTERY. THIS WAS THE SIXTH COIL OF THE PROCEDURE. THE PHYSICIAN DID NOT LIKE HOW THE COIL WAS COMING OUT OF THE CATHETER, SO AN ATTEMPT WAS MADE TO RETRIEVE THE COIL INTO THE CATHETER, BUT THE COIL STRETCHED. THERE WAS NO ATTEMPT TO DELIVER THE COIL, BUT THE COIL DETACHED IN THE CATHETER; THE PROXIMAL RELEASE PERFORATION WAS NOT BROKEN. THE COIL WAS IN THE INTENDED COMMON HEPATIC ARTERY, BUT WHEN THE COIL STRETCHED, IT ENDED UP MOVING INTO THE CELIAC ARTERY WITH THE STRETCHED PORTION EXTENDING INTO THE AORTA. NO PORTION OF THE COIL REMAINED IN THE TARGET LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE COIL STRETCHED WHEN THEY TRIED TO PULL IT BACK INTO THE SHEATH, AND THE COIL EVENTUALLY BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173905 ↗
• InjuryApr 12, 2023Break; Stretched; Malposition of Device; Break; Stretched; Malposition of Device

  IT WAS REPORTED THAT THE COIL DETACHED IN A NON-TARGET LOCATION AND HAD TO BE RETRIEVED FROM THE PATIENT WITH A SNARE CATHETER. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE AS THE FIRST COIL IN AN EMBOLIZATION PROCEDURE TO TREAT PULMONARY ARTERIOVENOUS MALFORMATIONS (AVMS). THE TARGET LESION WAS ACCESSED FROM THE FEMORAL VEIN AND WAS REPORTED TO HAVE MODERATE TORTUOSITY. DURING ADVANCEMENT TO THE TARGET LOCATION, THE COIL HAD TO BE REWOUND THREE-TO-FOUR TIMES DUE TO THE DEVICE SLIPPING WITHIN THE VEIN. IT WAS VISUALIZED THAT THE COIL HAD BEGUN TO UNRAVEL AS A RESULT OF THIS. IT WAS ATTEMPTED TO REMOVE THE DELIVERY SHAFT BY FOLDING THE PERFORATED SECTION OF THE PROXIMAL DELIVERY WIRE, WHICH RESULTED IN THE PULL WIRE BREAKING EXTERNALLY TO THE PATIENT AND THE COIL DETACHING INSIDE THE PATIENT. THE COIL WAS APPROACHED CONTRALATERALLY AND RETRIEVED WITH A SNARE CATHETER. NO DEVICE FRAGMENTS REMAINED WITHIN THE PATIENT. THE DEVICE WAS REPLACED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727836 ↗
• InjuryMar 24, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE DELIVERY WIRE BROKE, AND A DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. AN 8X20 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE AN EMBOLIZATION PROCEDURE. THE TARGET LOCATION WAS A PSEUDOANEURYSM IN THE PANCREATICODUODENAL. THE VESSEL WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED THE COIL DUE TO A SIZING PREFERENCE. WHILE TRYING TO RETRACT THE COIL INTO THE SHEATH, THERE WAS RESISTANCE, AND THE POLYMER SHAFT OF THE DELIVERY WIRE BROKE. THE PHYSICIAN WAS ABLE TO USE SALINE TO DEPLOY THE COIL WITH THE DISTAL FRAGMENT OF THE DELIVERY WIRE STILL ATTACHED TO THE COIL. THE COIL AND FRAGMENT OF THE DELIVERY WIRE WERE LEFT INSIDE THE TARGET LOCATION, AND NO ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16610101 ↗
• InjuryJan 27, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BROKE, AND THERE WAS AN UNRETRIEVED DEVICE FRAGMENT. AN 8X20 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, WHICH WAS ACCESSED VIA RADIAL APPROACH. MULTIPLE COILS, INCLUDING NON-BOSTON SCIENTIFIC COILS AND INTERLOCK, WERE USED TO TREAT. WHILE POSITIONING THE LAST 8X20 EMBOLD FIBERED, THE PHYSICIAN WAS NOT SATISFIED WITH THE FINAL PLACEMENT OF THE LAST 3CM OF THE COIL, AND A RESISTANCE WAS FELT. THEREFORE, AN ATTEMPT WAS MADE TO RETRACT THE COIL TO BETTER POSITION IT, BUT A RESISTANCE WAS FELT. THE DETACHMENT MECHANISM WAS NEVER TOUCHED OR ACTIVATED. THE COIL STRETCHED AND LIKELY BROKE AT THE COIL TO COUPLER WELD. MANY DEVICES (SNARES, TULIP, AND OTHER TOOLS) WERE USED TO TRY AND REMOVE THE DEVICE. SINCE A SNARE WAS ABLE TO REMOVE 3/4 OF THE COIL TAIL, THE COIL LIKELY BROKE AGAIN SOMEWHERE ON THE LENGTH DURING THAT SNARE REMOVAL. AFTER TWO HOURS, THE PHYSICIAN DECIDED TO LEAVE THE REMAINING 1/4 OF THE COIL INSIDE THE SPLENIC ARTERY AND CELIAC TRUNK. THE PATIENT'S STATUS WAS STABLE POST PROCEDURE. THERE IS NO PLAN TO REMOVE THE FRAGMENT AT A FUTURE DATE. THE PATIENT WILL BE UNDER SURVEILLANCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16253890 ↗