EmboCube® Initial ReleaseRecalls & reported problems
Biosphere Medical · Class 2 · Implant
Data updated Oct 16, 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 00884450306208), received between Apr 2, 2024 and Apr 2, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Embolism/Embolus1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A VASCULAR EMBOLIZATION PROCEDURE WITHIN THE PATIENT'S LIVER, THE PATIENT HAD CODED ON THE PROCEDURE TABLE, THE MEDICAL TEAM WAS USING RED CONTRAST SYRINGES DURING THIS PROCEDURE FOR FLUOROSCOPIC IMAGING, DURING THE PATIENT CODE, IT WAS FIRST REPORTED THAT THE MEDICAL TEAM MAY HAVE INADVERTENTLY GRABBED A RED EMBOLIC SYRINGE THINKING IT WAS CONTRAST SYRINGE AND INJECTED THE EMBOLIC INTO THE PATIENT'S VASCULAR SYSTEM. IT WAS ALSO REPORTED THAT THE PHYSICIAN DID AN EXTENSIVE "POST-PROCEDURE" REVIEW OF EVENTS THAT TOOK PLACE AND BELIEVES THAT THE PATIENT MAY HAVE EXPERIENCED REFLUX OF THE EMBOLIC MATERIAL THAT LED TO NON-TARGET EMBOLIZATION INSTEAD. REGARDLESS THE EMBOLIC PRODUCT ALLEGEDLY MIGRATED TO THE PATIENT'S LOWER LEG. THE PATIENT WAS REFERRED TO SURGERY FOR AMPUTATION. THE PATIENT WAS CRITICALLY ILL SUFFERING FROM SIMULTANEOUS COMORBIDITIES AND PRE-EXISTING COMPLICATIONS AT THE TIME.
Patient problems: Embolism/Embolus; Obstruction/Occlusion
MAUDE report 19028606 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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