EMBOLD™ Fibered M001394240100300Recalls & reported problems
Boston Scientific Corporation · Detachable Coil System · Class 2 · Implant
All models of EMBOLD Fibered (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729983644), received between Feb 1, 2024 and Jan 20, 2026 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Contamination
IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 10X30 EMBOLD FIBERED WAS SELECTED FOR AN EMBOLIZATION PROCEDURE OF SMA. DURING REMOVAL FROM THE HOOP, THE COIL SPRANG LOOSE AND WAS CONTAMINATED ON A MONITOR. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119921 ↗MalfunctionFeb 1, 2024Break; Break
IT WAS REPORTED THAT THE COIL BROKE. A 10MM X 30CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BROKE IN THE VESSEL. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18625829 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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