EMBOLD™ Soft M001394250020020Recalls & reported problems
Boston Scientific Corporation · Detachable Coil System · Class 2 · Implant
Data updated Oct 16, 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 00191506026363), received between May 5, 2026 and May 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Malposition of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Malposition of Device; Difficult or Delayed Separation
IT WAS REPORTED THAT MALPOSITION OF THE DEVICE OCCURRED. AN EMBOLD SOFT 2X2 COIL WAS SELECTED FOR AN EMBOLIZATION PROCEDURE FOR A LOWER GASTROINTESTINAL BLEED. THE COIL WAS DEPLOYED; HOWEVER, AFTER ATTEMPTED DETACHMENT, THE COIL WAS ADHERENT TO THE PUSHER WIRE. MULTIPLE MANEUVERS WERE ATTEMPTED TO RETRACT THE COIL INSIDE THE MICROCATHETER (TRUSELECT 130CM) BUT WERE NOT SUCCESSFUL. THE DECISION WAS MADE TO ATTEMPT TO RETRACT THE COIL AND MICROCATHETER TOGETHER UNTIL EXTERNALIZED. ONCE THE MICROCATHETER AND COIL CONTACTED THE BASE CATHETER, THE COIL DETACHED AND MIGRATED DOWN TO THE ILEOCOLIC ARTERY. A SUPERIOR MESENTERIC ARTERIOGRAM WAS PERFORMED VIA THE BASE CATHETER, SHOWING THE COIL IN A DISTAL BRANCH OF THE ILEOCOLIC ARTERY; HOWEVER, NO EVIDENCE OF DECREASED FLOW TO THE ILEOCOLIC SEGMENT WAS NOTED. NO FURTHER PRODUCTS WERE USED AFTER THE FACT. THE PATIENT BLOOD PRESSURE WAS STABILIZED AND PRESSOR SUPPORT WAS DISCONTINUED. THE PATIENT LEFT THE DEPARTMENT IN STABLE CONDITION WITH NO COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 25088275 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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