EMBOLD™ Fibered M001394240060200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729983613), received between Apr 26, 2023 and Jun 1, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Stretched” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Break; Difficult to Remove; Malposition of Device

  IT WAS REPORTED THAT THE COIL FRACTURED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT. AN EMBOLD? FIBERED 6X20 WAS SELECTED FOR USE TO TREAT AN ABDOMINAL AORTIC ANEURYSM ALONG WITH A TRUSELECT MICROCATHETER. PRIOR TO USE OF THE EMBOLD DEVICE, A NON-BOSTON SCIENTIFIC LIQUID EMBOLIC AGENT WAS USED TO TREAT THE LESION. THE TARGET VESSEL WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE, WHILE POSITIONING AND DEPLOYING THE COIL IN THE PROXIMAL INFERIOR MESENTERIC ARTERY, THERE WAS RESISTANCE ENCOUNTERED IN THE COIL DETACHMENT SYSTEM. AS A RESULT, THE COIL FRACTURED, WITH A FRAGMENT OF THE COIL BREAKING OFF WITHIN THE PATIENT. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE COIL FRAGMENT USING AN UNKNOWN 4MM MICRO-SNARE, BUT ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL FRAGMENT, WHICH WAS OBSERVED PROXIMALLY AT THE LEVEL OF THE LEFT COLIC ARTERY, OUTSIDE OF THE TARGET LESION. NO FURTHER INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25350626 ↗
• InjuryMay 20, 2026Difficult to Remove; Stretched; Material Protrusion/Extrusion; Migration

  IT WAS REPORTED THAT THE COIL MIGRATED AND REQUIRED ADDITIONAL INTERVENTION. AN EMBOLD? FIBERED 6X20 WAS SELECTED FOR USE TO TREAT A SPLENIC LACERATION. THE EMBOLD COIL WAS SUCCESSFULLY DEPLOYED INTO THE PROXIMAL SPLENIC ARTERY. STASIS WAS NOT ACHIEVED, SO THE PHYSICIAN FOLLOWED IT WITH A 45 CM NON-BOSTON SCIENTIFIC (BSC) PACKING COIL. BEFORE THEY FULLY DEPLOYED THE NON-BSC COIL, THE EMBOLD SHOT DISTALLY INTO THE SPLEEN. THE PHYSICIAN RESHEATHED THE NON-BSC PACKING AND SENT A SNARE TO RETRIEVE THE EMBOLD. THE PHYSICIAN WAS ABLE TO GRAB HOLD OF THE EMBOLD AND PULL IT BACK ALL THE WAY TO THE ORIGIN OF THE SPLENIC ARTERY, BUT WAS UNABLE TO RETRACT IT INTO THE MICROCATHETER. THE PHYSICIAN REPORTED SOME RESISTANCE AND ULTIMATELY ELECTED TO LEAVE THE EMBOLD IN THE PATIENT. THE PHYSICIAN USED EMBOLD 8X20 AND NON-BSC PACKING COILS TO BLOCK OFF THE PROXIMAL SPLENIC ARTERY. FOLLOW-UP CT IMAGING REVEALED THAT THE EMBOLD 6X20 HAD STRETCHED ALL THE WAY FROM THE SPLENIC ARTERY TO THE ACCESS SITE IN THE RIGHT GROIN. THE PATIENT WAS STARTED ON BABY ASPIRIN AND THE PHYSICIAN ORDERED FOLLOW UP IMAGING IN A COUPLE OF MONTHS. THERE WERE NO ADVERSE PATIENT SYMPTOMS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231150 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE COIL WAS FRACTURED DURING INSERTION. AN EMBOLD? FIBERED 6X20 WAS SELECTED FOR USE TO TREAT A GASTROINTESTINAL BLEED. DURING THE PROCEDURE, AS THE COIL WAS BEING INSERTED INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER, THE DISTAL TIP OF THE COIL FRACTURED. AS A RESULT, THE COIL WAS WITHDRAWN FROM THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE COIL DID NOT MAKE CONTACT WITH THE PATIENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037820 ↗
• MalfunctionMar 10, 2026Difficult to Remove; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LESION. AN EMBOLD? FIBERED WAS SELECTED FOR USE TO TREAT A GASTRIC ANEURYSM. THE TARGET LESION WAS A MILDLY CALCIFIED ANEURYSM SAC MEASURING 8CM X 6CM, AND THE PARENT VESSEL WAS MILDLY TORTUOUS. THE SAC WAS ACCESSED WITH A 2.8 NON-BOSTON SCIENTIFIC MICROCATHETER. AFTER APPROXIMATELY 18CM OF THE COIL WAS ADVANCED OUT OF THE MICROCATHETER, THE DECISION WAS MADE TO RETRACT THE COIL. THE COIL BEGAN TO STRETCH ALMOST IMMEDIATELY, RESULTING IN THE INABILITY TO REMOVE THE COIL. THE COIL WAS DEPLOYED, WITH THE STRETCHED FILAMENT HANGING OUT OF THE ANEURYSM SAC AND EXTENDING INTO THE PARENT VESSEL. NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561024 ↗
• InjuryDec 6, 2024Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE COIL BROKE, REQUIRING SNARING. A 6MM X 20CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION PROCEDURE. PRIOR TO THIS EVENT, A FEW EMBOLD COILS WERE SUCCESSFULLY DEPLOYED. DURING PLACEMENT OF THE LAST COIL, THE MICROCATHETER WAS IN THE COIL PACK WHEN IT WAS DETERMINED THAT THE COIL NEEDED TO BE RETRACTED. WHILE ATTEMPTING TO RETRACT, IT WAS DISCOVERED THE COIL WAS STUCK IN THE COIL PACK, AND THE COIL BEGAN TO UNWIND AND STRETCH. FURTHER ATTEMPTS TO RETRACT RESULTED IN THE COIL CONTINUING TO UNWIND UP TO THE SHEATH, AND THE COIL BROKE APART AND SNAPPED. THE COIL WAS SUCCESSFULLY SNARED OUT OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866469 ↗
• MalfunctionApr 15, 2024Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAR2024. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE. PRIOR TO BREAKING THE PROXIMAL RELEASE PERFORATION, THE PHYSICIAN COULD FEEL THAT THE COIL HAD DETACHED WITHIN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED AS ONE UNIT WITHOUT ISSUE. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE DISTAL COUPLER WAS DETACHED FROM THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104963 ↗
• MalfunctionMar 25, 2024Premature Activation; Stretched; Material Protrusion/Extrusion; Premature Activation; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THE COIL DEPLOYED PREMATURELY AND STRETCHED OUT OF THE TARGET LOCATION. MULTIPLE EMBOLD FIBERED DETACHABLE COIL SYSTEMS WERE SELECTED TO EMBOLIZE THE GASTRODUODENAL ARTERY (GDA) FOR AN UPPER GASTROINTESTINAL BLEED. TWO 5X15 EMBOLD FIBER COILS WERE DEPLOYED SUCCESSFULLY IN DISTAL GDA. AT THE GDA ORIGIN, THE 6X20 WAS DIFFICULT TO DEPLOY AND STRETCHED, CAUSING A FEW CM OF STRETCHED COIL TO REMAIN IN THE COMMON HEPATIC. THE PHYSICIAN DOES NOT BELIEVE THAT THE PATIENT WILL HAVE ANY ADVERSE EFFECTS FROM THE COIL. THE GDA MEASURED 2.3 DISTALLY AND 2.5 AT THE ORIGIN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975315 ↗
• MalfunctionDec 21, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2023. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE IN THE MICROCATHETER AND STRETCHED. A 6X20 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A TRANSSPLENIC GASTRIC VARICEAL EMBOLIZATION PROCEDURE. THE MICROCATHETER WAS FLUSHED; HOWEVER, THE COIL WOULD NOT ADVANCE WITH THE MICROCATHETER. THE WHOLE SYSTEM WAS PULLED OUT. THE PHYSICIAN REGAINED ACCESS AND DEPLOYED OTHER EMBOLD COILS SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS SEPARATED FROM THE DISTAL COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380583 ↗
• InjuryOct 3, 2023Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE COIL BROKE. A 6X20 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A BLEED. THE ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE WHILE REPOSITIONING THE COIL INSIDE THE VASCULATURE, THE COIL APPEARED THIN AND ELONGATED. NO RESISTANCE WAS NOTED. THEN THE COIL BROKE AT THE COUPLER AND HAD TO BE SNARED. THE DEVICE WAS REMOVED. AT THIS POINT IT WAS DETERMINED NO OTHER INTERVENTION WAS NEEDED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860219 ↗
• InjuryJun 15, 2023Break; Premature Activation; Difficult to Remove; Stretched; Break; Premature Activation; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THERE WAS AN UNRETRIEVED DEVICE LEFT IN THE PATIENT FOLLOWING AN UNSUCCESSFUL SNARE ATTEMPT. AN EMBOLD FIBERED 6X20 WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE TO TREAT A GASTRODUODENAL ARTERY (GDA) ANEURYSM. THE TARGET VESSEL WAS REPORTED TO BE TORTUOUS. WHEN THE COIL WAS ATTEMPTED TO BE RECONSTRAINED IN THE MICROCATHETER FOR BETTER PLACEMENT, THERE WAS RESISTANCE ENCOUNTERED, AND THE COIL APPEARED TO STRETCH. THE PHYSICIAN CONTINUED TO RETRACT THE DELIVERY WIRE, AT WHICH POINT SEVERAL SNAPPING SENSATIONS WERE FELT, AND THE COIL DETACHED AT THE POLYMER SHAFT, DISTAL TO THE PROXIMAL COUPLER. THE DELIVERY WIRE WAS WITHDRAWN FROM THE MICROCATHETER, AND A SNARE WAS USED TO ATTEMPT TO RETRIEVE THE COIL. THE COIL WAS UNABLE TO BE RETRIEVED, AND THE STRETCHED COIL ULTIMATELY REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THE UNRETRIEVED DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17137881 ↗
• MalfunctionApr 26, 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 DEPLOYED COIL PROTRUDED FROM THE TARGET LESION. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT THE ABDOMINAL AORTIC ANEURYSM. AFTER SUCCESSFULLY PLACING THREE EMBOLD FIBERED DETACHABLE COILS OF THE SAME SIZE WITHIN THE IMA, THERE WAS RESISTANCE ENCOUNTERED WHEN THE FOURTH COIL WAS ADVANCED. THE FOURTH COIL WAS ATTEMPTED TO BE REMOVED, BUT THE TIP OF THE COIL WAS STUCK, AND THE COIL SUBSEQUENTLY UNRAVELED. THE COIL WAS DEPLOYED WITHIN THE ANEURYSM, BUT PROTRUDED FROM THE TARGET LESION WITHIN THE IMA INTO THE AORTA. A STENT GRAFT WAS PLACED TO COMPLETE TREATMENT OF THE ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT. IT WAS FURTHER REPORTED THAT THE ANEURYSM WAS LOCATED AROUND THE ORIGIN OF THE IMA RATHER THAN WITHIN THE IMA. IT WAS ALSO CLARIFIED THAT THE RESISTANCE THAT WAS ENCOUNTERED WITH THE FOURTH EMBOLD WAS FELT DURING COIL DEPLOYMENT RATHER THAN DURING COIL ADVANCEMENT. ADDITIONAL INFORMATION CONFIRMED THAT THE STENT GRAFT FULLY TRAPPED THE UNRAVELED COIL WITHIN THE ANEURYSM. FINALLY, ALL FOUR COILS THAT WERE PLACED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818056 ↗