EMBOLD™ Fibered M001394240030120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729983552), received between Dec 1, 2023 and Jan 20, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026

  S [SITUATION]: DURING ANGIOGRAM COIL PARTIALLY DEPLOYED ITSELF PRIOR TO DEPLOYING THE COIL. B [BACKGROUND]: RENAL ARTERY EMBOLIZATION. A [ASSESSMENT]: COIL NOTED TO BE NOT WORKING PROPERLY. R [RESPONSE]: TOOK THAT COIL COMPLETELY OUT AND PUT NEW COIL IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115235 ↗
• MalfunctionSep 4, 2025Break; Stretched; Device-Device Incompatibility; Break; Stretched; Device-Device Incompatibility

  IT WAS REPORTED THAT COIL BREAK OCCURRED. AN EMBOLD FIBERED 3X12 WAS SELECTED FOR A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION PROCEDURE. THE COIL FELT FINE WHEN PUSHING THROUGH THE MICROCATHETER. HOWEVER, WHEN DEPLOYING IT, IT FELT LIKE IT GOT STUCK ON A PREVIOUSLY DEPLOYED COIL. WHILE TRYING TO LOOSEN THE COIL, IT STRETCHED AND BROKE. A PORTION OF THE COIL WAS REMOVED WITHIN THE MICROCATHETER. THE REMAINING PORTION WAS LEFT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22969439 ↗
• MalfunctionAug 9, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED COIL WAS REMOVED UNINTENTIONALLY BY ANOTHER COIL, AND THE COIL BROKE. A 3MM X 12CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM. AFTER PLACING ONE 3MM X 12CM EMBOLD FIBERED COIL, AN ATTEMPT WAS MADE TO PLACE ANOTHER 3MM X 12CM EMBOLD FIBERED COIL. INTERMITTENT FLUSHING WAS PERFORMED THROUGHOUT THIS PROCEDURE, BUT FLUSHING WAS NOT PERFORMED BEFORE INSERTING THE COIL. THERE WAS DIFFICULTY INSERTING THE DEVICE. THE COIL MADE IT TO THE DISTAL PART OF THE 0.027-INCH NON-BOSTON SCIENTIFIC MICROCATHETER, BUT THERE WAS RESISTANCE, SO IT WAS SUSPECTED THAT THE COIL HAD UNRAVELED. WHEN THE COIL WAS PULLED BACK INTO THE MICROCATHETER, THE PREVIOUSLY PLACED COIL WAS ALSO PULLED INTO THE MICROCATHETER. THE ENTIRE MICROCATHETER WAS REMOVED FROM THE BODY, AND WHEN THE COIL WAS REMOVED TO TRY TO INVESTIGATE THE EVENT, IT WAS DISCOVERED THAT ONE OF THE TWO COILS WAS MISSING. IT DID NOT REMAIN INSIDE THE BODY, AND IT DID NOT FALL INTO THE SURGICAL FIELD. IT WAS POSSIBLY STILL INSIDE THE MICROCATHETER. THE COIL THAT WAS FOUND APPEARED SEPARATED WITHOUT BEING UNRAVELED. THERE WERE NO PATIENT COMPLICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22766648 ↗
• InjuryJul 30, 2025Break; Material Protrusion/Extrusion; Difficult or Delayed Separation; Break; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL FRACTURED AND PORTIONS OF IT WERE SNARED FROM THE PATIENT. A FRACTURED PORTION OF THE COIL EXTENDED INTO A NON-TARGET LOCATION. AN EMBOLD? FIBERED WAS SELECTED FOR USE TO TREAT AN EMBOLIC FISTULA DURING A Y-90 MAPPING PROCEDURE. THE COIL PASSED THROUGH A TRUSELECT MICROCATHETER TO REACH THE TARGET LESION. WHEN THE PROXIMAL RELEASE PERFORATION WAS SNAPPED, IT APPEARED THAT A FILAMENT REMAINED ATTACHED TO THE COIL, AND BROKE OFF PROXIMALLY. PORTIONS OF THE COIL WERE SNARED OUT OF THE PATIENT. THE COIL WAS IN PLACE IN THE TARGET LESION, BUT PART OF THE FILAMENT EXTENDED DOWN INTO THE AORTA. THERE WAS NO FURTHER INTERVENTION REPORTED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22668560 ↗
• MalfunctionJul 9, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13JUNE2025. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 3X12 EMBOLD FIBERED WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING INSERTION, THE COIL PREMATURELY DEPLOYED IN THE TRUSELECT CATHETER. THE WHOLE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPETED WITH A 2X4 EMBOLD DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS DETACHED FROM THE COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457995 ↗
• MalfunctionApr 28, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 04APR2025. THE RETURNED DEVICE EVALUATION REVEALED THE COIL WAS DETACHED FROM THE COUPLER. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE. THIS 3X12 EMBOLD FIBERED EMBOLIC DEVICE WAS SELECTED FOR USE DURING A RENAL ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SELECTED THE RENAL ARTERY WITH A RENEGADE STC 130 CM WITH MINIMAL DIFFICULTY. IT WAS NOTED THERE WAS SOME TORTUOUS ANATOMY. THEY FLUSHED THE RENEGADE STC PRIOR TO ADVANCING THIS EMBOLD COIL, THEN LOADED AND ADVANCED THE COIL IN NORMAL FASHION. RESISTANCE WAS MET WHEN THE COIL APPROACHED THE DISTAL END OF THE RENEGADE STC. THEY ATTEMPTED TO FORM THE COIL IN THE VESSEL AND MET RESISTANCE AGAIN. THEY OPTED TO RECAPTURE THE COIL, AND TRY A SMALLER AND SHORTER EMBOLD COIL, WHICH ADVANCED AND DEPLOYED IN THE PATIENT WITHOUT DIFFICULTY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922907 ↗
• InjuryApr 1, 2025Break; Stretched; Device-Device Incompatibility; Break; Stretched; Device-Device Incompatibility

  IT WAS REPORTED THAT POST-DEPLOYMENT, THE COIL BECAME STUCK TO THE TIP OF THE MICROCATHETER, AND ADDITIONAL INTERVENTION WAS REQUIRED. A 3MM X 12CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM IN THE MILDLY TORTUOUS MEDIAN SACRAL ARTERY. INTERMITTENT FLUSHING WAS PERFORMED. THE COIL WAS ADVANCED THROUGH A 0.027INCH NON-BOSTON SCIENTIFIC MICROCATHETER. AFTER DEPLOYING THIS COIL, WHEN THE DELIVERY WIRE WAS PULLED, IT WAS FOUND THAT THE DISTAL COUPLER OF THE COIL WAS CONNECTED TO THE TIP OF THE MICROCATHETER. WHEN THE MICROCATHETER WAS PULLED, THE COIL WAS STILL CONNECTED. WHILE ATTEMPTING TO REMOVE THE MICROCATHETER TOGETHER WITH THE COIL, THE MICROCATHETER AND COIL BECAME SEPARATED INSIDE THE BODY. WHILE ATTEMPTING TO RETRIEVE THE COIL WITH A SNARE, THE COIL UNRAVELED/BROKE. THE COIL WAS OBSERVED TO BE STRETCHED AND BROKEN IN TWO PIECES. THE PART OF THE COIL THAT WAS GRASPED WITH THE SNARE WAS ABLE TO BE RETRIEVED, BUT THE OTHER HALF OF THE UNRAVELED COIL COULD NOT BE RETRIEVED AND REMAINED IN THE NON-TARGET INTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21741336 ↗
• InjuryMar 24, 2025Break; Difficult to Remove; Stretched; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Separation; Break; Difficult to Remove; Stretched; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL DEPLOYED IN A NON-TARGET VESSEL, AND THE DELIVERY WIRE BROKE. A 3MM X 12CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A PELVIC BLEED. THE VESSEL WAS A BRANCH OFF THE INTERNAL ILIAC WITH AN APPROXIMATE SIZE MEASUREMENT OF 2-3MM. THE VESSEL WAS NOT TORTUOUS BUT SMALL. 0.18 COILS WERE DEPLOYED THROUGH A 2.4F NON-BOSTON SCIENTIFIC MICROCATHETER. A 2X6 COIL WAS SUCCESSFULLY DEPLOYED AT THE MOST DISTAL POINT OF THE VESSEL IMMEDIATELY PRIOR TO THE USE OF THIS DEVICE. THIS COIL WAS PUSHED INTO THE VESSEL SUCCESSFULLY, AND THE PROXIMAL RELEASE PERFORATION WAS BROKEN IN ORDER TO DEPLOY THE COIL. THERE WAS RESISTANCE WHEN RETRACTING THE PULL WIRE. UPON ATTEMPTING TO REMOVE THE DELIVERY SYSTEM, THERE WAS RESISTANCE. AN ATTEMPT WAS MADE TO ADVANCE THE COIL TO GET IT TO DETACH, BUT THERE WAS ADDITIONAL RESISTANCE. THE MICROCATHETER WAS REMOVED AND WAS PULLED AGAINST THE RESISTANCE, RESULTING IN A SNAPPING FEELING. THE MICROCATHETER WAS REMOVED, AND IT WAS DETERMINED THAT THE POLYMER ZONE OF THE DELIVERY WIRE WAS STILL IN THE PATIENT. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED IN AN ATTEMPT TO ADVANCE THE COIL FROM THE NON-TARGET V

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 21678544 ↗
• InjurySep 13, 2024Migration; Migration

  IT WAS REPORTED THAT NON-TARGET EMBOLIZATION TO THE LEFT HEPATIC ARTERY OCCURRED. DURING A PROCEDURE TO TREAT BLEEDING OF THE GASTRODUODENAL ARTERY, MULTIPLE COILS WERE USED TO EMBOLIZE THE BLEED. DURING THE PROCEDURE, THIS 3 X 12 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS THE LAST TO IMPLANT; HOWEVER, THE COIL MIGRATED TO THE LEFT HEPATIC ARTERY RESULTING IN NON-TARGET EMBOLIZATION. THE PHYSICIAN ATTEMPTED TO USE A MICRO SNARE, BUT WAS UNABLE TO REMOVE THE COIL FROM THE BODY. ANOTHER COIL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 20217599 ↗
• MalfunctionJun 26, 2024Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31MAY2024. A 3X12 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE HEPATIC ARTERY AS PART OF A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE. DURING PREPARATION AFTER THE FLUSH, THE COIL WAS CHECKED FROM THE INTRODUCER SHEATH, AND THE COIL WAS OBSERVED TO BE UNRAVELED. THIS ISSUE WAS OBSERVED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL WAS DETACHED FROM THE DISTAL COUPLER AT THE WELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614123 ↗
• InjuryDec 21, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BROKE, REQUIRING ADDITIONAL INTERVENTION. A 3MM X12CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A HEMORRHOID EMBOLIZATION PROCEDURE. THE COIL WAS PARTIALLY DEPLOYED IN THE RECTAL ARTERY BRANCH WHEN AN ATTEMPT WAS MADE TO REPOSITION; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE BOTH PUSHING AND PULLING ON THE DELIVERY WIRE. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL INTO THE MICROCATHETER. THE OPERATOR PULLED WITH RESISTANCE, AND THE COIL STRETCHED AND ULTIMATELY BROKE. THE COIL SEPARATED FROM THE COUPLERS ON THE DELIVERY WIRE. MULTIPLE PASSES WERE MADE WITH BOTH STANDARD 6F SNARES AND MICROSNARES TO RETRIEVE PORTIONS OF THE STRETCHED COIL. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE COIL APPEARED TO SEPARATE BETWEEN THE COIL AND THE DISTAL COUPLER BEFORE MULTIPLE PASSES WITH SNARES WERE MADE TO REMOVE THE STRETCHED COIL. THE REMAINING COIL FRAGMENTS WERE LEFT IN THE NON-TARGET INFERIOR MESENTERIC ARTERY. APPROXIMATELY HOW MUCH OF THE COIL WAS LEFT IN THE PATIENT WAS UNABLE TO BE DETERMINED DUE TO THE STRETCHED LENGTH. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER COIL, AND THE TARGET LOCATION DID NOT APPEAR SUFFICIENTLY

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377427 ↗
• MalfunctionDec 1, 2023Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT THE COIL WAS DEPLOYED IN A NON-TARGET LOCATION. A 3MM X 12CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN A VARICOCELE EMBOLIZATION PROCEDURE. THE PLAN WAS TO EMBOLIZE A TRIBUTARY AND THEN THE MAIN VESSEL. DURING THE PROCEDURE, THE COIL INADVERTENTLY DETACHED INSIDE THE MICROCATHETER. WHILE ATTEMPTING TO PULL THE WIRE BACK, THE COIL RETRACTED AS WELL. IT SEEMED THE COIL HAD NOT FULLY DETACHED. THE COIL HAD TO BE REDEPLOYED. THE COIL WAS ADVANCED FORWARD AND DEPLOYED IN A MORE PROXIMAL POSITION INSIDE THE NON-TARGET VESSEL ABOVE THE TRIBUTARY. THEY COULD NO LONGER PERFORM THE DISTAL EMBOLIZATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS TO BE MONITORED FOR RESOLUTION OF SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247291 ↗