EMBOLD™ Fibered M001394240140300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729983705), received between Oct 30, 2023 and Sep 2, 2026 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break; Difficult to Remove; Difficult to Advance

  Patient problems: Foreign Body In Patient

  MAUDE report 50569942 ↗
• InjuryFeb 24, 2026Break; Difficult to Remove; Stretched; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL BROKE REQUIRING ADDITIONAL INTERVENTION. A 14X30 EMBOLD FIBERED WAS SELECTED FOR USE IN A RENAL ARTERY ANEURYSM EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY TORTUOUS. AFTER THE INITIAL ANGIOGRAM, IT WAS DETERMINED THE ANEURYSM WAS APPROXIMATELY 14MM IN DIAMETER. AFTER INTRODUCING THE COIL INTO THE VESSEL, DIFFICULTY OCCURRED WHILE FORMING THE COIL. AFTER SEVERAL REPOSITIONING ATTEMPTS, THE DISTAL PORTION OF THE COIL APPEARED TO FALL OUT OF THE ANEURYSM AND TRACK BACK TOWARD THE PARENT VESSEL. A KNOT FORMED IN THE MIDDLE OF THE COIL DURING RETRACTION OF THE COIL INTO THE 2.8 NON-BOSTON SCIENTIFIC MICROCATHETER. AN ATTEMPT TO REMOVE THE ENTIRE SYSTEM WAS MADE; HOWEVER, THE KNOT WAS TOO LARGE AND BECAME LODGED IN THE VESSEL. IT WAS THEN DETERMINED THAT THE ANEURYSM WAS ALSO ASSOCIATED WITH A VENOUS FISTULA, AND THE INITIAL COIL DEPLOYMENT HAD OCCURRED IN A 4MM VENOUS VESSEL, EXPLAINING WHY THE COIL WAS NOT FORMING PROPERLY. AT THIS POINT, THE LEFT FEMORAL VEIN WAS ACCESSED IN AN ATTEMPT TO REMOVE THE COIL FROM THE VENOUS SIDE. AFTER SNARING THE COIL AND PULLING, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE. THE COIL STRETCHED AND BROKE FROM THE COUPLERS WHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431747 ↗
• InjuryOct 22, 2024Break; Premature Activation; Difficult to Remove; Difficult to Advance; Break; Premature Activation; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THERE WERE UNRETRIEVED DEVICE FRAGMENTS. A 14X30 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM. THE ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DELIVERY WIRE THROUGH THE DIREXION MICROCATHETER. THE PHYSICIAN DID NOT ATTEMPT DEPLOYMENT, BUT WHILE ATTEMPTING TO RETRIEVE THE COIL TO REPOSITION, THE DELIVERY WIRE DETACHED AT THE TWO WHITE DEPLOYMENT MARKERS. AFTER DETACHMENT OF THE PROXIMAL RELEASE PERFORATION ON THE DELIVERY WIRE, THE COIL REMAINED ATTACHED TO THE PULL WIRE. THERE WAS DIFFICULTY RETRACTING THE PULL WIRE. TO COMPLETE DEPLOYMENT, THE COIL WAS PUSHED OUT WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE, AND THE MICROCATHETER WAS REMOVED. A FOGARTY BALLOON WAS INSERTED AND INFLATED INSIDE THE 5FR DIAGNOSTIC CATHETER TO ADVANCE THE COIL AS FAR INSIDE THE NEST. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PULL WIRE FROM THE SHEATH, BUT IT BROKE OFF OUTSIDE, SO MULTIPLE ATTEMPTS WERE MADE TO PUSH THE PULL WIRE OUTSIDE OF THE MICROCATHETER. APPROXIMATELY 150CM OF THE PULL WIRE REMAINED INSIDE THE PATIENT'S BODY WITH THE EMBOLD COIL. THE CASE WAS SUCCESSFULLY

  Patient problems: Foreign Body In Patient

  MAUDE report 20510039 ↗
• InjuryOct 30, 2023Difficult to Remove; Stretched; Material Protrusion/Extrusion; Difficult to Remove; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THE COIL UNRAVELED OUTSIDE OF THE TARGET LOCATION REQUIRING REMOVAL USING A SNARE. THIS EMBOLD FIBERED DETACHABLE COIL SYSTEM 14 X 30 WAS SELECTED FOR SPLENIC ARTERY EMBOLIZATION TO TREAT AN ANEURYSM. ON (B)(6) 2023, THE COIL UNRAVELED/STRETCHED WHEN BEING RETRACTED DURING PLACEMENT; HOWEVER, IT WAS THOUGHT TO BE FULLY CONTAINED WITHIN THE SPLENIC ARTERY. ON (B)(6) 2023, IMAGE REVEALED THE COIL EXTENDED FROM SPLENIC ARTERY DOWN THE AORTA AND INTO THE ILIAC ARTERY. ON (B)(6) 2023, AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE UNRAVELED COIL PORTION. THE UNRAVELED PORTION WAS SEPARATED INTO FRAGMENTS AND THEN REMOVED USING A SNARE. ON THAT SAME DAY, A FOLLOW-UP CT SHOWED NO RESIDUAL FRAGMENTS IN AORTA/ILIAC. ON (B)(6) 2023, ADDITIONAL IMAGING CONFIRMED THE REMAINING COIL WAS ONLY IN THE INTENDED SPLENIC ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034049 ↗