EMBOLD™ Fibered M001394240060100Recalls & 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
- 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 08714729983606), received between Aug 24, 2023 and Aug 24, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Stretched1
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.
MalfunctionAug 24, 2023Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched
IT WAS REPORTED THAT THE COIL FRACTURED INTERNALLY. AN EMBOLD FIBERED 6X10 WAS SELECTED FOR USE. THE PHYSICIAN WAS ATTEMPTING TO EMBOLIZE A COLLATERAL VESSEL THAT ORIGINATED OFF THE BRACHIAL AND WAS SHUNTING FLOW TO THE CEPHALIC VEIN IN A DIALYSIS SHUNT IN THE UPPER RIGHT ARM. A 4F 0.038 NON-BOSTON SCIENTIFIC CATHETER AND A RENEGADE HI-FLO- MICROCATHETER WERE IN PLACE IN THE COLLATERAL VESSEL. WHILE ATTEMPTING TO PLACE AN EMBOLD FIBERED 6X10 AND REPOSITION IT, A PORTION OF THE COIL APPEARED TO NOT PULL BACK INTO THE MICROCATHETER. IT WAS PRESUMED THAT THE COIL HAD FRACTURED, AND ALTHOUGH A MAJORITY OF THE COIL STAYED IN POSITION IN THE VESSEL, WHAT DID REMAIN WAS STRETCHED. THE MICROCATHETER AND COIL PUSHER WIRE WERE REMOVED AS ONE UNIT TO FLUSH THE MICROCATHETER AND ENSURE THAT NO REMNANTS OF THE COIL REMAINED IN THE CATHETER. THE MICROCATHETER WAS REINSERTED AND THE PHYSICIAN ATTEMPTED TO PLACE AN ADDITIONAL EMBOLD FIBERED 6X10 NEXT TO THE REMAINDER OF THE FIRST EMBOLD FIBERED 6X10. BEFORE THE PROXIMAL RELEASE PERFORATION WAS BROKEN, THE PHYSICIAN ATTEMPTED TO REPOSITION THE SECOND COIL, AT WHICH POINT BOTH COILS BECAME ENTANGLED AND WERE UNINTENTIONALLY PULLED BACK INTO THE MICR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17616889 ↗
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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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