Embosphere® 00884450403204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450403204), received between Apr 9, 2026 and Jun 2, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Fracture; Leak/Splash

  THE CUSTOMER REPORTED WHEN THE OUTER PACKAGING WAS OPENED, THE DOCTOR NOTICED THAT THE SHAPE AND STRUCTURE OF THE EMBOSPHERE INSIDE THE SYRINGE WERE ALTERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363729 ↗
• MalfunctionMay 26, 2026Contamination

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN PREPPING THE EMBOSPHERE SYRINGE, IT WAS NOTICED BY THE TECH AND PHYSICIAN THAT A SMALL GREEN OBJECT WAS IN THE SYRINGE. SALINE AND CONTRAST WERE ADDED BY USING A BLUE BOWL AND NOTHING GREEN WAS REPORTED IN THE STERILE FIELD. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285055 ↗
• MalfunctionApr 14, 2026Crack

  THE CUSTOMER REPORTS WHEN THE CAP ON THE SYRINGE IS TURNED OPEN, IT WILL CRACK AND THE LIQUID WILL COME OUT MAKING IT UNUSABLE. THERE WAS NO INJURY TO THE PATIENT AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873508 ↗
• InjuryApr 13, 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 24858691 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS THERE WERE RED SKIN RASHES OBSERVED ON THE PATIENT'S LEFT KNEE AREA POSSIBLY RELATED TO THE USE OF THE DEVICE. COLD COMPRESS WAS APPLIED AND THIS RESOLVED THE ISSUE. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Rash

  MAUDE report 24829909 ↗

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, Classified
  Embosphere 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-