EMBOLD™ Fibered M001394240050080Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729983583), received between Jun 10, 2025 and Jun 10, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult or Delayed Separation1
- Difficult to Advance1
- Malposition of Device1
- 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.
InjuryJun 10, 2025Break; Stretched; Malposition of Device; Difficult to Advance; Difficult or Delayed Separation; Break; Stretched; Malposition of Device; Difficult to Advance; Difficult or Delayed Separation
IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED, THE COIL WAS SNARED, AND THE COIL BROKE. A 5MM X 8CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN A RIGHT RENAL MASS EMBOLIZATION PROCEDURE. SEVERAL 4MM X 8CM COILS AND ONE 5MM X 8CM COIL WERE PLACED. WHILE ATTEMPTING TO PLACE THE LAST COIL (THIS 5MM X 8CM EMBOLD FIBERED COIL), IT WAS DIFFICULT TO GET THE LAST BIT OF THE COIL INTO THE VESSEL. ONCE THEY DID, UPON DEPLOYING THE COIL, THE COIL WANTED TO COME BACK INTO THE MICROCATHETER AND FAILED TO DETACH. WHILE ATTEMPTING TO SLOWLY RECAPTURE THE COIL IN ORDER TO REMOVE IT, THE COIL DEPLOYED BUT WAS NO LONGER WHERE IT NEEDED TO BE; THE COIL WAS IN THE MAIN RENAL ARTERY. TO AVOID EMBOLIZING THE ENTIRE RIGHT KIDNEY, THE COIL WAS SNARED BUT BROKE INTO TWO PIECES WHEN PULLING IT OUT. BOTH PIECES WERE RETRIEVED. THE CATHETER, SNARE, AND COIL WERE REMOVED ALL TOGETHER. IMAGING WAS ABLE TO CONFIRM THAT THE COIL WAS FULLY REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175791 ↗
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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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