EMBOLD™ Fibered M001394240320600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506010485), received between May 13, 2024 and Sep 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Break; Difficult to Remove; Stretched; Material Deformation; Material Integrity Problem; Break; Difficult to Remove; Stretched; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL BROKE, AND THERE WERE UNRETRIEVABLE DEVICE FRAGMENTS REQUIRING ADDITIONAL INTERVENTION. A 32MM X 60CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN A 3CM SPLENIC ANEURYSM EMBOLIZATION PROCEDURE. THE VESSEL WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, INTERMITTENT FLUSHING WAS PERFORMED, AND THE COIL WAS ADVANCED THROUGH A 2.8F NON-BOSTON SCIENTIFIC CATHETER. WHILE ATTEMPTING TO GET THE COIL TO FORM, THE COIL KEPT FLYING DOWN THE OUTFLOW VESSEL. THREE ATTEMPTS TO REPOSITION THE COIL WERE MADE WHEN IT WAS OBSERVED THAT THE COIL WAS NOT RESPONDING TO THE PHYSICIAN'S MOVEMENTS. RESISTANCE WAS FELT. SNARING WAS ATTEMPTED ON THE PROXIMAL END FOR OVER AN HOUR UNSUCCESSFULLY. THE COIL STRETCHED AND WAS UNABLE TO COME OUT; THE COIL BROKE AND KEPT FRAGMENTING DURING RETRIEVAL ATTEMPTS. THE COIL WAS PARTIALLY EXPLANTED, BUT A PORTION REMAINS IMPLANTED. THE PROCEDURE WAS PROLONGED, AND ADDITIONAL SURGERY WAS REQUIRED.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 22952722 ↗
• MalfunctionJul 22, 2025Break; Difficult to Remove; Stretched; Material Deformation; Break; Difficult to Remove; Stretched; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BROKE. A 32MM X 60CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN VARICEAL EMBOLIZATION FOLLOWING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE NON-TORTUOUS VESSEL WAS ACCESSED USING A NON-BOSTON SCIENTIFIC MICROCATHETER. THE PHYSICIAN ATTEMPTED TO PLACE THE COIL IN A LARGE VARICOSE; HOWEVER, THE COIL DID NOT ANCHOR, SO MULTIPLE ATTEMPTS TO REPOSITION WERE MADE. THE COIL RELEASE MECHANISM WAS NEVER ACTIVATED. WHEN ATTEMPTING TO REMOVE THE COIL, IT APPEARED TO KNOT RESULTING IN STRETCHING AND THE DELIVERY WIRE BECOMING DETACHED. THE PHYSICIAN WAS ABLE TO FULLY REMOVE EVERYTHING BY PULLING THE STRETCHED COIL. THE PROCEDURE WAS COMPLETED WITH IDC 35 COILS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572327 ↗
• MalfunctionMay 13, 2024Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO INSERT INTO THE MICROCATHETER. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE TO TREAT A BLEED. THE EMBOLD COIL WAS ATTEMPTED TO BE INSERTED INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER WITH INTERMITTENT FLUSHING, BUT THE COIL WOULD NOT ADVANCE. USE OF THE EMBOLD COIL WAS ABANDONED, AND IT WAS DETERMINED THAT A COIL WAS NOT NECESSARY TO TREAT THE BLEED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DISTAL COUPLER HAD DETACHED FROM THE MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299445 ↗