Embosphere® 00884450403174Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450403174), received between Apr 10, 2026 and Jun 24, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
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 Problem2
- Defective Component1
- Fracture1
Patient problems
- Reaction to Medicinal Component of Device2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN STATES THAT HE STARTED TO SEE HIVES ON PATIENT'S KNEES CORRESPONDING TO THE EMBOLIZATION TREATMENT SITE AFTER GENICULAR ARTERY EMBOLIZATION (GAE) PROCEDURES. HE HAS HAD MULTIPLE OCCURRENCES OVER THE LAST COUPLE OF MONTHS BUT JUST REPORTED ON TWO PATIENTS LAST WEEK. THE HIVES REACTION WAS NOTICED POST PROCEDURE; ONE WAS WHILE THE PATIENT WAS IN RECOVERY AND FOR THE OTHER ONE, THEY GOT A HOLD OF THE PHYSICIAN THE FOLLOWING DAY WITH HIVES AND RASH. THE HIVES SUBSIDE WITH BENADRYL.
Patient problems: Reaction to Medicinal Component of Device
MAUDE report 25609611 ↗MalfunctionApr 17, 2026Fracture; Defective Component
THE CUSTOMER REPORTED AN EMBOLIZATION PROCEDURE WAS PERFORMED AFTER ANGIOGRAPHY AND THE EMBOSPHERE WAS SUSPENDED IN ACCORDANCE WITH STANDARD PROCEDURE. WHILE CONNECTING THE 3-WAY Y VALVE FOR INJECTION BY SMALL SYRINGE, IT WAS NOTE THAT THE LUER JOINT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909512 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTS THE PATIENT EXPERIENCED HIVES AT THE SITE OF TREATMENT AFTER A GENICULAR ARTERY EMBOLIZATION (GAE) PROCEDURE. THE HIVES SUBSIDED WITH ADMINISTRATION OF BENADRYL. THE DEVICE HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Reaction to Medicinal Component of Device
MAUDE report 24845489 ↗
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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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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