Embosphere® 00884450403402Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450403402), received between Jan 8, 2024 and Jan 8, 2024 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K181300); they may or may not involve this specific model.
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
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES POST A BILATERAL UTERINE ARTERY EMBOLIZATION PROCEDURE THE PATIENT EXPERIENCED SEVERE POSTOPERATIVE ABDOMINAL PAIN, WHICH REQUIRED ORAL NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, PTERIDINE INTRAMURAL INJECTION, AND MORPHINE SUBCUTANEOUS INJECTION FOR PAIN RELIEF. AFTER ABOVE TREATMENT, ABDOMINAL PAIN WAS GRADUALLY RELIEVED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Abdominal Pain
MAUDE report 18466527 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K181300. One submission often covers many models, so check the product and lot details in each record.
- Z-3305-2026 · Aug 10, 2026 · Open, ClassifiedEmbosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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