EMBOLD™ Fibered M001394240120300Recalls & 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 08714729983675), received between Jun 18, 2024 and Apr 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 reports).
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
- Difficult to Remove2
- Activation, Positioning or Separation Problem1
- Failure to Advance1
- Material Deformation1
- Premature Activation1
- Stretched1
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.
MalfunctionApr 24, 2026Difficult to Remove; Stretched; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation
REPORTABLE BASED ON ANALYSIS COMPLETED ON 07APR2026. THE RETURNED DEVICE EVALUATION REVEALED THE COIL WAS DETACHED FROM THE DISTAL COUPLER. A 12X30 EMBOLD? FIBERED DEVICE WAS USED DURING A LEFT SUBCLAVIAN EMBOLIZATION PROCEDURE TO TREAT A BLEED. THE COIL WOULD NOT FRAME THE WAY THE SURGEON WANTED DURING DEPLOYMENT; THEREFORE, THE SURGEON RETRACTED AND ADVANCED THE COIL MULTIPLE TIMES BEFORE WITHDRAWING THE COIL. ON FINAL WITHDRAWAL, RESISTANCE WAS NOTED, AND THE COIL FORMED A KNOT, AND THE COIL WAS UNABLE TO BE ADVANCED OR RETRACTED INTO THE MICROCATHETER. THE COIL STRETCHED AS THE SURGEON ATTEMPTED TO PULL IT THROUGH THE MICROCATHETER. THE COIL AND CATHETER WERE REMOVED AS THERE WAS A LONG LINE OF FILAMENT DUE TO THE STRETCH. THE BLEEDING WAS STOPPED USING TWO CLIPS, AND THE PATIENT EXPERIENCED NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984581 ↗MalfunctionJun 18, 2024Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove
REPORTABLE BASED ON ANALYSIS COMPLETED ON 28-MAY-2024. THE RETURNED DEVICE EVALUATION REVEALED THE COIL WAS DETACHED FROM THE DISTAL COUPLER. IT WAS REPORTED THAT THE DEVICE PREMATURELY DEPLOYED. THIS 12X30 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A SPLENIC ANEURYSM PROCEDURE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO PLACE THE COIL AND RETRACT FOR FURTHER PLACEMENT. THE DEVICE PREMATURELY DEPLOYED, PARTIALLY INSIDE THE PATIENT AND PARTIALLY IN THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW MICROCATHETER AND COIL. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562703 ↗
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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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