Embosphere® 00884450116296Recalls & reported problems
Biosphere Medical · Class 2 · Implant
All models of Embosphere (18)
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 00884450116296), received between Apr 14, 2026 and Apr 14, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Illegible Information” (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
- Illegible Information1
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.
MalfunctionApr 14, 2026Illegible Information
THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS LIKE 2026 INSTEAD OF 2025, HENCE THE HOSPITAL REJECTED AND RETURNED THE UNUSED PRODUCT TO DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874013 ↗
Other AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS devices
- Embosphere® 00884450116715Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall8 reports
- HydroPearl HP2S0600Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 recall0 reports
- Embosphere® 00884450109519Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall0 reports
- Embosphere® 00884450098561Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450098424Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450106051Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS3 reports
- Cook G09665Cook Incorporated · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- Bearing nsPVA® 00884450123317Merit Medical Systems, Inc. · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
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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