EMBOLD™ Soft M001394250060300Recalls & reported problems
Boston Scientific Corporation · Detachable Coil System · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506026547), received between Mar 16, 2026 and Mar 16, 2026 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Malposition of Device1
- Material Protrusion/Extrusion1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Break; Premature Activation; Malposition of Device; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED, AND PROTRUDED FROM THE TARGET LESION. AN EMBOLD SOFT 6X30 WAS SELECTED FOR USE TO TREAT A GASTROINTESTINAL BLEED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED GASTRODUODENAL ARTERY (GDA), WHICH WAS 6 MM IN DIAMETER. DURING USE OF THE EMBOLD SOFT 6X30, THE COIL DEPLOYED PREMATURELY WITHIN THE MICROCATHETER WITHOUT BREAKING THE PROXIMAL RELEASE PERFORATION. AS A RESULT, THE PHYSICIAN WAS UNABLE TO POSITION THE COIL PRECISELY WITHIN THE TARGET LESION. THE PHYSICIAN WAS ABLE TO PUSH THE COIL OUT OF THE MICROCATHETER, BUT A PORTION OF THE COIL EXTENDED FROM THE GDA INTO THE HEPATIC ARTERY. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED, AND NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS EXPECTED TO RECOVER FULLY. IT WAS FURTHER CLARIFIED THAT THE COIL BROKE WITHIN THE MICROCATHETER AT THE COUPLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606925 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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