EMBOLD™ Fibered M001394240100500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729983651), received between May 18, 2023 and Aug 3, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• InjuryAug 3, 2026Stretched; Device-Device Incompatibility; Material Protrusion/Extrusion

  It was reported that the coil stretched out of the target location.A 10mm x 50cm EMBOLD? Fibered coil was selected for use in an embolization procedure of the non-tortuous left ovarian vein. The target vessel diameter was 6-7 mm. The patient was being treated for pelvic congestion. The distal left ovarian vein was embolized with two EMBOLD? Fibered coils successfully. Afterwards, the proximal ovarian vein was embolized with two EMBOLD? Fibered coils. It appeared normal and the whole delivery system and microcatheter were pulled out of the ovarian vein; however, in doing so, the second to last coil became entangled with either the microcatheter or the 5Fr catheter, resulting in the coil unraveling with a strand stretched out. A fine strand of the coil extended all the way back into the sheath through the inferior vena cava (IVC). During removal of the microcatheter, tension on this strand pulled the proximal portion of the coil up into the renal vein. The team was able to reposition the proximal portion of the coil back into the ovarian vein; however, despite several hours of effort, using various guidewires and snares, they were unable to retrieve the remaining strand that extended

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116340 ↗
• InjuryJul 31, 2026Stretched

  It was reported that the coil stretched within the patient, resulting in additional intervention.An EMBOLD? Fibered 10x50 was selected for use for a splenic artery embolization. The Embold coil was deployed but was noted to stretch due to the non-Boston Scientific catheter kinking. The stretched coil was successfully retrieved and fully explanted using a snare. The procedure was successfully completed using an alternate coil. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100696 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE SHAFT BROKE DURING COIL DELIVERY. AN EMBOLD? FIBERED 10X50 WAS SELECTED FOR USE IN THE VASCULAR EMBOLIZATION PROCEDURE. THE TARGET LOCATION WAS MODERATELY TORTUOUS AND LOCATED IN THE INTERNAL ILIAC ARTERY. DURING COIL DELIVERY, THE DEVICE SHAFT BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166470 ↗
• MalfunctionJan 20, 2026Break; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL STRETCHED AND BROKE WITHIN THE PATIENT. AN EMBOLD? FIBERED WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY. A NON-BOSTON SCIENTIFIC MICROCATHETER WAS INSERTED VIA THE CONTRALATERAL APPROACH, AND THE COIL WAS POSITIONED AND DEPLOYMENT WAS INITIATED BY BREAKING THE PROXIMAL RELEASE PERFORATION. WHEN APPROXIMATELY 5 CM OF THE COIL REMAINED TO BE DEPLOYED, THE COIL BEGAN TO STRETCH. THE MICROCATHETER WAS CAREFULLY WITHDRAWN FROM THE LESION TO PREVENT THE COIL FROM DEPLOYING FULLY. AS THE MICROCATHETER WAS PULLED, THE STRETCHED PORTION OF THE COIL BROKE OFF WITHIN THE PATIENT. THE MICROCATHETER AND MAJORITY OF THE COIL WERE WITHDRAWN FROM THE PATIENT. RETRIEVAL OF THE DETACHED PORTION OF THE COIL WOULD HAVE PROVED DIFFICULT DUE TO A TORTUOUS ANATOMY, SO THE PHYSICIAN ELECTED TO USE A PLANNED STENT GRAFT TO PRESS THE REMAINING PORTION OF THE COIL INTO PLACE. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24121704 ↗
• InjuryDec 4, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE DEVICE BROKE REQUIRING ADDITIONAL INTERVENTION. A 10X50 EMBOLD FIBERED WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. THE VESSEL WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS A LITTLE LARGE. THE DEVICE DETACHED BETWEEN THE DISTAL COUPLER AND THE COIL DURING RETRACTION. THE PROXIMAL END OF THE COIL STRETCHED. FRAGMENTS OF THE STRETCHED COIL WERE LEFT BEHIND INSIDE THE PATIENT. ONCE THE PHYSICIAN SAW THE STRETCHED COIL, APPROXIMATELY AN HOUR WAS SPENT TRYING TO SNARE IT OUT, BUT WHEN IT WAS SNARED, IT WOULD BREAK APART. AN ANGIOGRAM REVEALED THAT THE VESSEL WAS SHUT DOWN; THEREFORE, NO FURTHER INTERVENTION WAS NEEDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23715952 ↗
• InjuryDec 2, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE COIL FRACTURED REQUIRING ADDITIONAL INTERVENTION. A 10X50 EMBOLD FIBERED WAS SELECTED FOR USE IN A PRE-EVER RIGHT INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE. THE TARGET LOCATION WAS MODERATELY TORTUOUS. RESISTANCE WAS FELT DURING PLACEMENT OF THE COIL AND THE COIL UNRAVELED. A FRACTURE WAS OBSERVED AND ANOTHER EMBOLD COIL WAS PLACED. THE FRACTURED COIL WAS RETAINED AT THE LESION SITE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23695613 ↗
• MalfunctionJul 16, 2025Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2025. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. AN EMBOLD FIBERED 10X50 WAS SELECTED TO TREAT AN AORTIC ANEURYSM. THERE WAS RESISTANCE WHEN INSERTING THE COIL, SO IT WAS WITHDRAWN AND FLUSHED WITH SALINE ONCE. THEN IT WAS REINSERTED, BUT THE RESISTANCE DID NOT RESOLVE. THE COIL WAS REMOVED WITH THE BREAKTHROUGH 2MARKER MICROCATHETER AND CHECKED, AND IT HAD APPEARED TO BE DETACHED WITHIN THE MIDDLE PART OF THE MICROCATHETER. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A COIL BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522070 ↗
• MalfunctionAug 10, 2023Material Protrusion/Extrusion; Difficult or Delayed Separation; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LOCATION. AN EMBOLD FIBERED 10X50 DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE. THE COIL WAS INTENDED TO BE DEPLOYED DISTALLY IN THE VARICOCELE VEIN. THE PHYSICIAN ADVANCED THE COIL TO THE TARGET LOCATION OF DEPLOYMENT AND ENSURED THAT THE COUPLERS WERE OUTSIDE OF THE MICROCATHETER BEFORE BREAKING THE PROXIMAL RELEASE PERFORATION TO DEPLOY THE COIL, BUT THE COIL DID NOT DETACH. THE PHYSICIAN RETRACTED THE PULL WIRE FURTHER, BUT THE COIL STILL DID NOT DEPLOY. THE MICROCATHETER WAS PULLED BACK AND AN ALTERNATE PUSHER WIRE WAS UTILIZED TO PUSH THE COIL INTO THE TARGET LOCATION. DUE TO THE ADDITIONAL MANIPULATION, THE PROXIMAL TIP OF THE COIL WAS DEPLOYED MORE PROXIMALLY IN THE VESSEL THAN INTENDED. THE PROXIMAL PORTION OF THE COIL PROTRUDED FROM THE TARGET LESION. NO FURTHER ACTION WAS TAKEN AS A RESULT OF THE UNINTENDED COIL PLACEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504645 ↗
• MalfunctionJul 19, 2023Separation Failure; Material Protrusion/Extrusion; Separation Failure; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE DEPLOYED COIL EXTENDED INTO A NON-INTENDED LOCATION, WHICH INTERFERED WITH SUBSEQUENT PLANNED STENT GRAFT PLACEMENT. AN EMBOLD FIBERED 10X50 WAS SELECTED FOR USE IN THE ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. THE TARGET LESION WAS AN ABDOMINAL AORTIC ANEURYSM LOCATED IN THE INTERNAL ILIAC. THE INTERNAL ILIAC BONE WAS EMBOLIZED WITH PREOPERATIVE EMBOLISM. THE LESION WAS ACCESSED VIA A CONTRALATERAL APPROACH FROM THE UPPER AND LOWER GLUTE OF THE RIGHT INTERNAL ILIAC TO THE INTERNAL ILIAC ANEURYSM ENTRY SITE. THE EMBOLD DELIVERY SYSTEM WAS ADVANCED THROUGH A BREAKTHROUGH 2 MARKER MICROCATHETER. WHEN THE EMBOLD COIL WAS AT THE ANEURYSM ENTRY, THE COIL DID NOT RELEASE, DESPITE THE COUPLERS BEING ADVANCED PAST THE MICROCATHETER TIP. THE PROXIMAL RELEASE PERFORATION WAS NOT BROKEN. AFTER ADVANCING AND RETRACTING THE COIL SEVERAL TIMES, IT EVENTUALLY DETACHED, BUT A PORTION OF THE COIL PROTRUDED INTO THE COMMON ILIAC BIFURCATION, OUTSIDE OF THE INTENDED DEPLOYMENT SITE. THE PROTRUDING PORTION OF THE COIL INTERFERED WITH SUBSEQUENT PLANNED STENT GRAFT PLACEMENT. HOWEVER, THE STENT GRAFT WAS EVENTUALLY SUCCESSFULLY PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351729 ↗
• MalfunctionMay 26, 2023Premature Activation; Device-Device Incompatibility; Premature Activation; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02MAY2023. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10X50 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR AN EMBOLIZATION OF THE RENAL ARTERIOVENOUS (AV) FISTULA. THE DEVICE WAS ADVANCED AND AT APPROXIMATELY 50% DEPLOYMENT, THE DEVICE BECAME RESISTANT AND STUCK. THE PUSH WIRE WAS NOT DEPLOYED; HOWEVER, BECAME DETACHED FROM THE COIL AND WAS HALF IN THE MICROCATHERER AND HALF IN THE VESSEL. A V-18 GUIDEWIRE WAS ADVANCE TO ATTEMPT TO PUSH THE COIL OUT OF THE MICROCATHETER, BUT BECAME STUCK WITH THE COIL. THE ENTIRE SYSTEM WAS REMOVED WITH THE COIL HALF IN THE MICROCATHETER AND STUCK WITH GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH EMBOLD COILS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010496 ↗
• InjuryMay 18, 2023Break; Premature Activation; Device-Device Incompatibility; Material Integrity Problem; Break; Premature Activation; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL FRACTURED AND DEPLOYED PREMATURELY. BOTH PIECES OF THE COIL HAD TO BE SNARED. A 10X50 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A SPLENIC ARTERY EMBOLIZATION PROCEDURE. MULTIPLE COILS WERE DEPLOYED WITHOUT ISSUE USING A NON-BOSTON SCIENTIFIC MICROCATHETER. THE PHYSICIAN WAS ATTEMPTING TO POSITION THE EMBOLD COIL BUT ENCOUNTERED DIFFICULTY IN THE COIL FORMING AS HE INTENDED. TO ASSIST IN POSITIONING, THE DELIVERY SYSTEM WAS ADVANCED IN AND OUT OF THE MICROCATHETER MULTIPLE TIMES. DURING ONE OF THESE ADVANCEMENTS, THE COIL BROKE IN HALF, WHICH PREMATURELY DEPLOYED THE DISTAL PORTION OF THE COIL INTO THE ARTERY WHILE THE PROXIMAL PORTION OF THE COIL REMAINED IN THE MICROCATHETER. THE PROXIMAL PORTION OF THE COIL WAS THEN PUSHED OUT INTO THE ARTERY USING A SYRINGE. NEITHER PORTION OF THE COIL WAS IN AN IDEAL LOCATION, SO THE PHYSICIAN ELECTED TO RETRIEVE BOTH FRAGMENTS. DURING RETRIEVAL OF ONE OF THE PIECES, WHILE PULLING BACK THE COIL USING A SNARE, THE EMBOLD COIL HOOKED ONTO THE COIL PACK AND BEGAN PULLING IT BACK. AFTER SOME MANEUVERING, BOTH PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956290 ↗