Embosphere® 00884450403426Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450403426), received between Apr 14, 2026 and Jun 4, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TIP WAS OPEN AND THERE WAS NOT ENOUGH FLUID IN THE PARTICLES. THERE WAS NO MEDICAL INTERVENTION OR PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393245 ↗
• MalfunctionJun 2, 2026Break

  THE CUSTOMER REPORTS THE SYRINGE BROKE DURING USE DURING PREP. THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363735 ↗
• MalfunctionApr 17, 2026Leak/Splash

  THE CUSTOMER REPORTED THAT BEFORE THE PROCEDURE, THEY FOUND THE SALINE HAD LEAKED. THE PROCEDURE WAS COMPLETED WITH NEW PRODUCT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909586 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKED LIKE 2026 INSTEAD OF 2025, HENCE THE HOSPITAL REJECTED AND RETURNED THE UNUSED PRODUCT TO DISTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870658 ↗

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-