EMBOLD™ Soft M001394250030150Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506026431), received between May 28, 2026 and May 28, 2026 — classified as 1 injury.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Break; Malposition of Device
IT WAS REPORTED THAT THE DEVICE FRACTURED, RESULTING AN AN UNRETRIEVED DEVICE FRAGMENT (UDF). AN EMBOLD? SOFT WAS SELECTED FOR USE TO EMBOLIZE A GASTRIC ARTERY BLEED. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS POSITIONING THE COIL, THE COIL BROKE AND DETACHED WITHIN THE PATIENT'S HEPATIC ARTERY, OUTSIDE OF THE TARGET LESION. RETRIEVAL ATTEMPTS WERE ABLE TO RETRIEVE A PORTION OF THE BROKEN COIL, BUT THE PHYSICIAN ELECTED TO LEAVE A FRAGMENT OF THE COIL WHERE IT WAS, AS RETRIEVAL WAS DIFFICULT. NO FURTHER INFORMATION WAS PROVIDED, DESPITE REQUEST BY BOSTON SCIENTIFIC.
Patient problems: Foreign Body In Patient
MAUDE report 25316913 ↗
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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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