EMBOLD™ Fibered M001394240020060Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729983538), received between Jun 24, 2022 and Sep 3, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Premature Activation; Stretched; Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599520 ↗
• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT A BREAK OCCURRED. A 2X6 EMBOLD FIBERED WAS SELECTED FOR USE. DURING THE PROCEDURE, OTHER COILS WERE DEPLOYED PRIOR TO THE 2X6 EMBOLD FIBERED COIL. A PORTION OF THE 2X6 EMBOLD FIBERED SHAFT WAS DAMAGED AND BROKE OFF ALONGSIDE THE COIL. THE DEVICE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472305 ↗
• MalfunctionMay 13, 2026Difficult to Remove

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 16-APR-2026. THE RETURNED DEVICE EVALUATION REVEALED A COIL BREAK FROM THE DISTAL COUPLER. IT WAS REPORTED THAT A 2X6 EMBOLD? FIBERED COIL WAS BEING LOADED INTO A RENEGADE STC MICROCATHETER TO TREAT A TRAUMA BLEED DURING AN EMBOLIZATION PROCEDURE. WHEN ATTEMPTING TO RETRACT THE COIL AFTER IT HAD BEEN PARTIALLY INSERTED, RESISTANCE WAS ENCOUNTERED AT THE MIDDLE/DISTAL PORTION OF THE CATHETER AND THE COIL FELT STUCK. AFTER SOME MANIPULATION, THE COIL WAS REMOVED SUCCESSFULLY AND THE DETACHMENT MECHANISM REMAINED INTACT. A NEW EMBOLD COIL WAS THEN USED AND ADVANCED WITHOUT ANY ISSUES. THE ATTENDING PHYSICIAN WAS NOT CERTAIN IF THEY EXPERIENCED ANY DIFFICULTIES WHILE LOADING THE COIL. THE CASE CONCLUDED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162941 ↗
• MalfunctionFeb 3, 2026Premature Activation; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 23JAN2026. THE RETURNED DEVICE EVALUATION REVEALED THE COIL WAS BROKEN. THIS 2X6 EMBOLD? FIBERED DEVICE WAS SELECTED FOR USE DURING A SPLENIC ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, AFTER THE FIRST COIL WAS DEPLOYED, THEY SELECTED ANOTHER VESSEL TO EMBOLIZE AND REQUESTED THIS 2X6 EMBOLD. AS THEY WERE ADVANCING THE COIL AND HAD REMOVED THE INTRODUCER SHEATH, THE COIL WAS ONLY ABLE TO ADVANCE 80% THROUGH THE MICROCATHETER. THE COIL WAS RESHEATHED AND ATTEMPTED AGAIN; HOWEVER, THE SAME ISSUE WAS OBSERVED. THE COIL WAS PULLED BACK TO RELOAD INTO THE SHEATH; HOWEVER, THE SAME RESISTANCE WAS NOTED. IT WAS THEN DECIDED TO PULL THE COIL OUT OF THE MICROCATHETER, BUT IT WAS NOTICED THAT THE COIL WAS NOT ATTACHED TO THE PUSHER WIRE. IT WAS THEN OBSERVED VIA FLUOROSCOPY OF THE ORIGINAL INTRODUCER SHEATH THAT THE COIL WAS STILL STUCK IN THE INTRODUCER SHEATH. AT THAT POINT THEY DECIDED TO USE A NESTER COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251417 ↗
• MalfunctionDec 11, 2025Failure to Advance

  WHEN DEPLOYING THE COIL IT WAS HARD TO MOVE AND ADVANCE FORWARD. WE TRIED RESHEATHING IT AND FLUSHING AND IT WAS TRYING TO COME OUT A SIDE HOLE AND WOULD NOT ADVANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778252 ↗
• MalfunctionSep 3, 2025Unraveled Material

  PATIENT WAS TAKEN TO THE OR FOR EMERGENT ANGIOGRAM/EMBOLIZATION. DURING ATTEMPTED EMBOLIZATION OF A SMALL CORTICAL BRANCH ARTERY, A BOSTON SCIENTIFIC EMBOLD DETACHABLE FIBERED COIL DEPLOYED AND UNRAVELED UNEXPECTEDLY. THIS PROMPTED A PROLONGED PROCEDURE TO REMOVE A PORTION OF THE UNRAVELED COIL. ULTIMATELY A LONG PORTION OF IT WAS REMOVED, HOWEVER A SMALL UNRAVELED FIBER WAS UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22951598 ↗
• InjuryAug 27, 2025Break; Premature Activation; Difficult to Remove; Stretched; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Premature Activation; Difficult to Remove; Stretched; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE BROKE. A 2MM X 6CM EMBOLD? FIBERED COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED. DURING THE PROCEDURE, THE COIL AND MICROCATHETER PROLAPSED OUT OF THE TARGET VESSEL. DURING ATTEMPTED REMOVAL OF THE COIL, IT DETACHED AND UNRAVELED WITHIN THE MICROCATHETER. IT WAS DIFFICULT TO REMOVE THE UNRAVELED FIBERS, AND NOT ALL OF THE PIECES WERE ABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE ATTEMPTED EMBOLIZATION WAS OF A SMALL CORTICAL BRANCH ARTERY. THE PROCEDURE WAS PROLONGED DUE TO ATTEMPTS TO REMOVE THE UNRAVELED COIL. ULTIMATELY A LONG PORTION OF IT WAS REMOVED; HOWEVER, A SMALL, UNRAVELED FIBER WAS UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22904553 ↗
• InjuryMay 20, 2025Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT A COIL BREAK OCCURRED REQUIRING INTERVENTION. THIS PATIENT WAS RECEIVING EMBOLIZATION OF A BRANCH OF THE GASTRODUODENAL ARTERY TO TREAT A BLEED. DURING THE PROCEDURE, ACCESS WAS GAINED INTO THE TARGET VESSELS, AND EMBOLIZATION OF THREE OTHER VESSELS WAS SUCCESSFULLY PERFORMED. DURING THE LAST VESSEL EMBOLIZATION WITH THIS 2 X 6 CM EMBOLD FIBERED COIL, THE PHYSICIAN REPOSITIONED THE COIL TWICE TO GET A BETTER PACK USING INTERMITTENT FLUSH. AFTER THE SECOND REPOSITION, THE COIL HAD SLIGHT RESISTANCE DEPLOYING AND HAD STRETCHED. WHILE THE PHYSICIAN WAS SNARING OUT THE STRETCHED COIL, THE COIL BROKE, AND THEY HAD TO SNARE MULTIPLE TIMES TO REMOVE ALL THE COIL FROM THE VESSEL. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052746 ↗
• MalfunctionMay 14, 2025Break; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Difficult or Delayed Separation; Break; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL BROKE AND STRETCHED OUTSIDE THE TARGET LOCATION. A 2MM X 6CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN INTERCOSTAL ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL AND COUPLERS WERE ADVANCED OUTSIDE THE MICROCATHETER TIP WITH SOME RESISTANCE, BUT EVEN AFTER BREAKING THE PROXIMAL RELEASE PERFORATION AND PULLING THE PULL WIRE, THE COIL DID NOT RELEASE. THEREFORE, THE COIL WAS PULLED, AND UNRAVELING OCCURRED. THE COIL EVENTUALLY BROKE AT THE LINK PART AND WAS PLACED INSIDE THE BODY. THE DESIRED INTERCOSTAL ARTERY WAS EMBOLIZED, BUT PART OF THE PROXIMAL SIDE OF THE COIL WAS UNRAVELED AND HANGING DOWN INTO THE AORTA. THE PROXIMAL SIDE OF THE DEVICE FROM THE LINK PART WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22020185 ↗
• MalfunctionFeb 4, 2025Malposition of Device; Difficult or Delayed Separation; Malposition of Device; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL DEPLOYED IN AN UNINTENDED LOCATION. A 2MM X 6CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN ESOPHAGEAL ARTERY EMBOLIZATION PROCEDURE. THE COIL WAS ADVANCED THROUGH A TRUSELECT MICROCATHETER. UPON BREAKING THE PROXIMAL RELEASE PERFORATION AND PULLING BACK, THE COIL DID NOT DEPLOY. THE SYSTEM WAS PULLED BACK, AND THE COIL DETACHED IN AN UNINTENDED LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THE TARGET VESSEL SIZE WAS 2MM AND LOCATED IN SEVERELY TORTUOUS ANATOMY. THE COIL DEPLOYED IN THE LEFT HEPATIC ARTERY. NO ACTIONS TAKEN OR PLANNED TO CORRECT THE COIL'S PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304743 ↗
• MalfunctionNov 19, 2024

  MULTIPLE COILS WOULD NOT DEPLOY FROM THE WIRE INSIDE THE PATIENT. 3 WERE REMOVED. THE 4TH ONE EVENTUALLY DEPLOYED AND MIGRATED FROM THE GASTRODUODENAL ARTERY TO THE HEPATIC ARTERY. STAFF TRIED TO SNARE THE COIL, BUT WAS UNSUCCESSFUL. STAFF HAD TO STOP THE PROCEDURE AFTER SEVERAL ATTEMPTS TO REMOVE THE COIL. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ FIBERED (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ PACKING (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ SOFT (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ FIBERED (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722621 ↗
• MalfunctionOct 22, 2024Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01OCT2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO INSERT. A 2X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) INTUBATION PROCEDURE IN THE ABDOMINAL AORTA. DURING THE PROCEDURE WHILE USING THE INTERMITTENT FLUSHING METHOD, HOWEVER, THE COIL BECAME STUCK IN THE HUB PART OF THE CATHETER. ONLY THE COIL WAS REMOVED AS IT WAS. A NEW EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED AND MISSING COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509934 ↗
• InjuryJun 24, 2024Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT THE COIL PREMATURE DEPLOYED IN A NON-TARGET VESSEL AND WAS ATTEMPTED TO BE REMOVED. THIS 2X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A RENAL EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL PREMATURELY DEPLOYED IN THE PATIENT'S VASCULATURE AND WAS NOT PLACED CORRECTLY IN THE TARGET LOCATION. NUMEROUS ATTEMPTS WERE MADE TO REMOVE THE COIL WITHOUT SUCCESS. AN ADDITIONAL COIL WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19598793 ↗
• MalfunctionJun 11, 2024Break; Malposition of Device; Difficult or Delayed Separation; Break; Malposition of Device; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL MALPOSITIONED. A 2X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN PRE-Y-90 EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS PLACED, AND THE PERFORATION WAS SNAPPED AS NORMAL DEPLOYMENT GOES; HOWEVER, THE COIL DID NOT DEPLOY. UPON FURTHER PULLING OF THE PULL WIRE, THE PULL WIRE BROKE. KELLY FORCEPS WERE USED TO GRAB THE WIRE WITH THE COIL STILL CONNECTED. WHEN REMOVED, IT MOVED THE COIL. THE COIL MISPOSITIONED AND COULD NOT BE REPOSITIONED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THIS COIL WAS INTENDED TO BE PLACED IN THE VESSELS LEADING TO THE LIVER. AFTER THE PULL WIRE BROKE, THE COIL EVENTUALLY DEPLOYED, BUT WHEN THE DELIVERY WIRE WAS PULLED, IT MOVED THE COIL FROM ITS INTENDED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514966 ↗
• InjuryMar 25, 2024Break; Stretched; Material Protrusion/Extrusion; Physical Resistance/Sticking; Break; Stretched; Material Protrusion/Extrusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL STRETCHED FROM THE GROIN INTO THE AORTA. A 2X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A GASTROINTESTINAL (GI) BLEED EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE COIL WAS ATTEMPTED TO BE IMPLANTED IN AN ILEOCOLIC BRANCH. AFTER BREAKING THE PROXIMAL RELEASE PERFORATION AND PULLING BACK THE PULL WIRE, RESISTANCE WAS EXPERIENCED REMOVING THE DELIVERY SYSTEM OF THE COIL. THE COIL STRETCHED FROM THE GROIN INTO THE AORTA. SEVERAL HOURS WERE SPENT ATTEMPTING TO SNARE THE COIL, BUT IT WAS UNSUCCESSFUL. THE COIL CONTINUED TO STRETCH. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR). THE SURGERY WAS SUCCESSFUL AT RETRIEVING 99% OF THE COIL, BUT A SMALL AMOUNT WAS LEFT IN THE DISTAL PORTION OF THE VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18969259 ↗
• InjuryJun 23, 2023Break; Material Deformation; Difficult or Delayed Separation; Break; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE COIL FRACTURED WITHIN THE PATIENT, AND ADDITIONAL INTERVENTION WAS UNABLE TO RETRIEVE ALL FRAGMENTS OF THE COIL. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE TO TREAT BLEEDING WITHIN A VISCERAL ARTERY. THIS WAS INTENDED TO BE THE LAST COIL PLACED VIA A NON-BSC CATHETER, AFTER PLACING ANOTHER EMBOLD COIL. THE END OF THE EMBOLD COIL WAS REPORTED TO BE BENT AND THERE WAS VISIBLE COUPLING WIRE PULLED BACK. THE PHYSICIAN THOUGHT THE COIL WAS OUTSIDE THE MICROCATHETER TIP, AND TRIED TO PULL BACK THE NITINOL WIRE, BUT THE COIL WAS STILL ATTACHED. THE COIL WAS ADVANCED AGAIN, MORE OF THE NITINOL WIRE WAS PULLED BACK, BUT THE COIL WAS STILL ATTACHED. THE PHYSICIAN THEN DECIDED TO REMOVE THE COIL FROM THE MICROCATHETER AND THE PATIENT. IT WAS NOT CONFIRMED THE COIL WAS OUTSIDE THE MICROCATHETER. THE MICROCATHETER WAS FLUSHED WITH NO ISSUE UNDER FLUOROSCOPY. ANOTHER COIL WAS OPENED, AND UPON INSERTION, IT WAS DISCOVERED THE PREVIOUS COIL WAS STILL IN THE MICROCATHETER. SINCE THE MICROCATHETER HAD MOVED BACK, THE SECOND COIL WAS PUSHED INTO A NON-TARGET LOCATION. THE REPLACEMENT COIL WAS REMOVED AND NOT DEPLOYED. THE PHYSI

  Patient problems: Foreign Body In Patient

  MAUDE report 17192944 ↗
• InjuryJun 24, 2022Break; Difficult to Remove; Stretched; Malposition of Device; Material Integrity Problem; Break; Difficult to Remove; Stretched; Malposition of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL BROKE. THE EMBOLIZATION TARGET WAS THE MILDLY TORTUOUS PROSTATIC ARTERY, <2MM DIAMETER. TARGET SITE WAS ACCESSED WITH A STRAIGHT 130CM TRUSELECT MICROCATHETER. ACCESS WAS VIA RIGHT FEMORAL TO EXTERNAL ILIAC TO INTERNAL ILIAC (SAME SIDE) THROUGH A DIAGNOSTIC CATHETER AND INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS A 'CROSSOVER' TYPE, ALLOWING IT TO BEND INTO THE INTERNAL ILIAC, WITH THE TIP NEAR THE OSTIUM OF THE PROSTATIC ARTERY. TWO 2X4 EMBOLD FIBERED COILS WERE DEPLOYED AT THE TARGET SITE AND FORMED ADEQUATELY. ANOTHER 2X4 WAS REQUESTED BUT WASN'T AVAILABLE, SO A 2X6 EMBOLD FIBERED COIL WAS USED. APPROXIMATELY 2CM OF THE 2X6 COIL DEPLOYED STRAIGHT DOWN THE VESSEL AND DID NOT TAKE A SHAPE. RETRACTION OF THE 2X6 COIL WAS ATTEMPTED BUT RESULTED IN COIL STRETCHING. VESSEL SPASM LIKELY OCCURRED, CONSTRAINING THE DEPLOYED COIL SEGMENT AND CONTRIBUTING TO THE COIL RETRACTION DIFFICULTY. THE PHYSICIAN CONTINUED TO RETRACT THE STRETCHED COIL, RESULTING IN A COIL WIRE BREAK. THE EMBOLD DELIVERY WIRE WAS THEN REMOVED FROM THE MICROCATHETER. BOTH COUPLERS WERE OBSERVED TO BE ATTACHED TO THE DELIVERY WIRE, WITH APPROXIMATELY 1MM OF COIL WIRE STILL ATTACHED. A CO

  Patient problems: Vasoconstriction

  MAUDE report 14803961 ↗