Embosphere® 00884450109519Recalls & reported problems
Biosphere Medical · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 10, 2026Open, Classified
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
Z-3305-2026 · Root cause: Process control · FDA record ↗
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® 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
- Embosphere® 00884450110621Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- HydroPearl 8HP2S200Microvention, 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page