EMBOLD™ Fibered M001394240120500Recalls & 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 08714729983682), received between Oct 29, 2024 and May 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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
- Adverse Event Without Identified Device or Use Problem1
- Separation Failure1
- 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.
MalfunctionMay 27, 2026Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED AND UNRAVELED. AN 12X50 EMBOLD? FIBERED WAS SELECTED FOR USE IN A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED GASTRIC VEIN. DURING THE PROCEDURE, THE COIL DID NOT DETACH, DESPITE BENDING AND PULLING THE DETACHMENT MARKER PART BEYOND THE PROXIMAL MARKER. THE COIL UNRAVELED. THE COIL AND THE PUSHER WERE COMPLETELY RETRIEVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED COIL SEPARATION FROM THE DISTAL COUPLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25305892 ↗MalfunctionOct 29, 2024
> 60-YEAR-OLD MALE WITH HISTORY OF PORTAL HYPERTENSION, TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT AND CIRRHOSIS UNDERWENT MECHANICAL THROMBECTOMY OF OCCLUDED TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT. DURING THE PROCEDURE, COIL DID NOT DEPLOY PROPERLY AND WAS COILING UP INSIDE OF THE CATHETER. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556244 ↗
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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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