Embosphere® 00884450110621Recalls & reported problems
Biosphere Medical · Class 2 · Implant
- 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 00884450110621), received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionMay 29, 2026Fluid/Blood Leak
THE CUSTOMER REPORTED FOR THE EMBOSPHERE THAT THERE WAS PRODUCT LEAKAGE. THERE WAS NO PATIENT CONTACT OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334326 ↗
Other AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS devices
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- Embosphere® 00884450109519Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall0 reports
- HydroPearl HP2S0600Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 recall0 reports
- Embosphere® 00884450098424Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450098561Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450106051Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS3 reports
- Bearing nsPVA® 00884450123317Merit Medical Systems, Inc. · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- HydroPearl 8HP2S200Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.