EMBOLD™ Fibered M001394240180500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729983729), received between Feb 6, 2023 and Jun 1, 2026 — classified as 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Premature Activation; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON PRODUCT ANALYSIS ON (B)(6) 2026. AN EMBOLD? FIBERED WAS SELECTED FOR USE TO TREAT A SPLENIC ARTERY ANEURYSM. DURING COIL POSITIONING, THE PHYSICIAN ATTEMPTED TO RECAPTURE THE COIL, BUT THERE WAS RESISTANCE ENCOUNTERED, AND THE COIL BEGAN TO FRAY. THE COIL PREMATURELY DEPLOYED WITHIN THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349953 ↗
• InjuryApr 24, 2026Break; Stretched; Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT INTERNAL DEVICE FRACTURE OCCURRED REQUIRING INTERVENTION. AN 18X50 EMBOLD? FIBERED WAS SELECTED FOR PULMONARY EMBOLIZATION TO TREAT AN ANEURYSM. DURING THE PROCEDURE, HOWEVER, IT WAS NOTED THAT THE COIL MOVED SLOWLY THROUGH THE RENEGADE AND NON-BOSTON SCIENTIFIC MICROCATHETERS. WHEN DEPLOYING THE COIL, THE COIL WAS NOT ABLE TO DETACH OR RETRACT. THE COIL BECAME STUCK, SO IT HAD TO BE REMOVED WITH A SNARE. WHILE REMOVING THE COIL, IT BROKE INTO MULTIPLE PIECES. THE DEVICE WAS EXPLANTED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981018 ↗
• InjuryNov 2, 2023Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE COIL BROKE AND THERE WERE UNRETRIEVED DEVICE FRAGMENTS. AN 18MM X 50CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR A HEPATIC ARTERY EMBOLIZATION TO TREAT A HEPATIC ARTERY ANEURYSM. THE VESSEL WAS SIGNIFICANTLY TORTUOUS. DURING THE PROCEDURE WHILE DEPLOYING THE FOURTH COIL WITH INTERMITTENT FLUSHING, THE COIL HAD PARTIALLY DEPLOYED IN THE SAC AND THEN WAS ATTEMPTED TO DEPLOY BACK INTO THE ARTERY FEEDING THE PSEUDOANEURYSM. DURING COIL RETRACTION, A LOT OF RESISTANCE WAS FELT. THINKING THAT THE COIL PREMATURELY DETACHED, THE PHYSICIAN CONTINUED TO PULL BACK ON THE NITINOL PUSHER WIRE. THEY FOUND THAT THE COIL WAS STILL ATTACHED TO THE PUSHER AND THE COIL HAD UNRAVELED INSIDE THE PATIENT. WHILE CONTINUING TO PULL, THE COIL CONTINUED TO UNRAVEL UNTIL IT EVENTUALLY SNAPPED. MULTIPLE ATTEMPTS WERE MADE AT SNARING THE COIL FOR RETRIEVAL AS A SINGLE PIECE AND WAS UNSUCCESSFUL. A COMBINATION OF MICRO SNARE AND FORCEPS WERE USED TO REMOVE THE COIL FRAGMENTS IN PIECES. THE RIGHT COMMON FEMORAL ARTERY ACCESS WAS UPSIZED AND A SNARE WAS THEN USED TO CAPTURE REMAINING FRAGMENTS OF COIL WITHIN THE AORTA. NOT ALL PIECES WERE RETRIEVED SUCCESSFULLY, AND PARTIAL P

  Patient problems: Foreign Body In Patient

  MAUDE report 18059426 ↗
• InjuryJun 9, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE BROKE, AND THERE WAS AN UNRETRIEVED DEVICE FRAGMENT. AN 18X50 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE SPLENIC ARTERY. WHILE ATTEMPTING TO RETRACT THE COIL BACK INTO THE SHEATH BECAUSE THE COIL WAS TOO LARGE, RESISTANCE WAS ENCOUNTERED. THE POLYMER SHAFT SNAPPED, AND THE COIL BROKE. NO ATTEMPTS WERE MADE TO RETRIEVE THE SHAFT FRAGMENT. THE COIL AND SHAFT FRAGMENT WERE LEFT IN THE TARGET LOCATION. MORE COILS WERE DEPLOYED WITHOUT ISSUE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17097452 ↗
• InjuryFeb 6, 2023Premature Activation; Difficult to Remove; Material Protrusion/Extrusion; Premature Activation; Difficult to Remove; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN ATTEMPTING TO REMOVE THE EMBOLD COIL, WHICH RESULTED IN THE COIL DEPLOYING INADVERTENTLY AND UNINTENTIONALLY EMBOLIZING THE COLLATERAL VESSEL. AN EMBOLD FIBERED 18X50 WAS SELECTED FOR USE DURING THE ENDOLEAK PROCEDURE. THE PHYSICIAN USED TWO EMBOLD FIBERED 14X50 COILS TO FILL THE ENDOLEAK THROUGH A COLLATERAL VESSEL, AND THEN PROCEEDED TO ADVANCE THE EMBOLD 18X50 THROUGH A 130CM TRUSELECT MICROCATHETER. THE 18X50 WAS SLIGHTLY TOO LARGE, SO THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL AND REMOVE IT FROM THE PATIENT. AS THE ENTIRE SYSTEM WAS ATTEMPTED TO BE REMOVED, THE COIL MET RESISTANCE AND DETACHED FROM THE PUSHER WIRE, INADVERTENTLY DEPLOYING. THE COIL WAS HALFWAY INTO THE TARGET LOCATION, BUT THE REMAINDER OF THE COIL WAS IN THE COLLATERAL VESSEL. THERE WAS NO POSSIBILITY OF SNARING OUT THE COIL. AS A RESULT OF THE INADVERTENT DEPLOYMENT, THE COLLATERAL VESSEL WAS UNINTENTIONALLY EMBOLIZED. MULTIPLE IMAGES WERE ORDERED TO ENSURE THAT THE COLLATERAL VESSEL WAS NOT NEEDED TO SUPPLY ADEQUATE BLOOD FLOW TO ALL NEIGHBORING ORGANS. IMAGING REVEALED THE COLLATERAL VESSEL WAS NOT NEEDED. THE PHYSICIAN ESTABLISHED THAT THE COIL HAD NO POTENT

  Patient problems: Embolism/Embolus

  MAUDE report 16308664 ↗