EMBOLD™ Soft M001394250080600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506026578), received between Apr 29, 2024 and Apr 28, 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.

• MalfunctionApr 28, 2025Break; Difficult to Insert; Difficult to Remove; Material Integrity Problem; Break; Difficult to Insert; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP BROKE. AN 8MM X 60 CM EMBOLD SOFT COIL WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE TIP BROKE DUE TO DIFFICULTY RE-CAPTURING INTO THE INTRODUCER SHEATH. THE DEVICE WAS EXCHANGED FOR ANOTHER ONE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922542 ↗
• InjuryDec 19, 2024Break; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL BROKE, AND A PORTION REMAINED IN THE VESSEL. AN EMBOLD SOFT 8X60 WAS SELECTED FOR A PROCEDURE. DURING THE RETRACTION OF THE COIL, HOWEVER, RESISTANCE WAS FELT, AND THE COIL STRETCHED AND BROKE. A PORTION OF THE COIL WAS REMOVED, WHILE THE BROKEN PORTION WAS LEFT IN THE TARGET VESSEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20979221 ↗
• MalfunctionApr 29, 2024Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. AN 8MM X 60CM EMBOLD SOFT DETACHABLE COIL SYSTEM AND A 60CM EMBOLD PACKING DETACHABLE COIL SYSTEM WERE SELECTED FOR USE IN A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM. THE ANATOMY WAS TORTUOUS. A TRUSELECT MICROCATHETER WAS USED TO DELIVER THE 8MM X 60 CM EMBOLD SOFT COIL FIRST. HOWEVER, IT WAS DETERMINED THAT THE COIL WAS UNDERSIZED, SO IT WAS RETRACTED BACK INTO THE MICROCATHETER. THE COIL PREMATURELY DEPLOYED FROM THE DELIVERY WIRE. THE MICROCATHETER WAS PULLED OUT WITH THE DEPLOYED COIL INSIDE, AND ACCESS WAS LOST. AFTER ACCESS WAS RE-GAINED, AND EMBOLD FIBERED COIL WAS SUCCESSFULLY DEPLOYED. FOLLOWING THAT, THE 60CM EMBOLD PACKING COIL WAS ADVANCED. THE COIL WAS NOT SITTING LIKE THE PHYSICIAN WANTED, SO THE COIL WAS RETRACTED. THE COIL PREMATURELY DEPLOYED, AND THE MICROCATHETER WAS PULLED TO REMOVE THE COIL. AFTER ACCESS WAS RE-GAINED, THE CASE WAS COMPLETED WITH NON-BOSTON SCIENTIFIC COILS. ONE OF THE NON-BOSTON SCIENTIFIC COILS ALSO PREMATURELY DEPLOYED DURING THIS CASE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209484 ↗