EMBOLD™ Soft M001394250060600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506026554), received between Jun 11, 2024 and Feb 5, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Break; Premature Activation; Difficult to Remove; Failure to Advance; Malposition of Device; Material Integrity Problem; Break; Premature Activation; Difficult to Remove; Failure to Advance; Malposition of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL INADVERTENTLY DEPLOYED OUTSIDE OF THE TARGET LESION, REQUIRING ADDITIONAL INTERVENTION. AN EMBOLD SOFT 6X60 WAS SELECTED FOR USE TO TREAT A TYPE TWO ENDOLEAK. THE TARGET LESION WAS MILDLY TORTUOUS. WHEN THE EMBOLD COIL WAS INSERTED, THE DEVICE BEGAN TO BUCKLE AND WAS REPORTEDLY HARD TO PUSH. THE PHYSICIAN BEGAN TO PULL BACK THE DEVICE, AT WHICH POINT THE COIL SNAPPED AND DETACHED. THE PHYSICIAN ATTEMPTED TO SNARE THE COIL, BUT THE COIL APPEARED TO FRAY AND COME APART. TO PREVENT THE COIL FROM MIGRATING DOWN THE LEG, A STENT WAS PLACED ACROSS THE ILIAC. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315408 ↗
• MalfunctionJun 11, 2024Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL STRETCHED AND PROTRUDED FROM THE TARGET LOCATION. A 6X60 EMBOLD SOFT WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE OF A PANCREATICODUODENAL ARTERY ANEURYSM. THE ANEURYSM WAS PACKED WITH MULTIPLE COILS OF VARIOUS TYPES, WHICH INCLUDED NON-BOSTON SCIENTIFIC COILS FOLLOWED BY TWO 6X60 EMBOLD SOFT COILS. THEN A THIRD 6X60 EMBOLD SOFT WAS DELIVERED AND PACKED INTO THE ANEURYSM. THE COIL HAD TO BE RETRACTED AND ADVANCED A BIT TO GET IT IN THE PROPER LOCATION, BUT IN THE END, THE PHYSICIAN WAS HAPPY WITH LOCATION IN THE ANEURYSM. THE COIL WAS DETACHED, BUT THE COIL DID NOT SEPARATE FROM THE DELIVERY WIRE; INSTEAD, THE COIL CAME BACK WITH THE DELIVERY WIRE. THE COUPLERS WERE NOTED TO BE OUT OF THE MICROCATHETER TIP WHEN DETACHING. THE PHYSICIAN ATTEMPTED TO ADVANCE AND RETRACT A BIT TO TRY TO GET THE COUPLERS TO SEPARATE. HOWEVER, DURING THIS PROCESS, THE COIL STRETCHED, AND THE PHYSICIAN PULLED THE ENTIRE DELIVERY SYSTEM OUT OF THE MICROCATHETER TIP. THE STRETCHED COIL CAME BACK WITH THE DELIVERY SYSTEM. THE PHYSICIAN CUT THE COIL WIRE AT THE MICROCATHETER HUB AND PUSHED THE COIL WIRE THAT REMAINED IN THE MICROCATHETER INTO THE PATIENT'S ANATOMY. ATTEMPTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514955 ↗