EMBOLD™ Soft M001394250020080Recalls & reported problems
Boston Scientific Corporation · Detachable Coil System · Class 2 · Implant
Data updated Oct 18, 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 00191506026394), received between Feb 3, 2025 and Feb 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
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.
MalfunctionFeb 3, 2025Failure to Advance; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2025. A 2X8 EMBOLD SOFT COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL WOULD NOT ADVANCE THOUGH THE 2.8F 130CM NON-BOSTON SCIENTIFIC MICROCATHETER. THE COIL WAS REMOVED THROUGH THE DELIVERY CATHETER, AND ANOTHER EMBOLD COIL WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED COIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21298256 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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