Embosphere® 00884450106051Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450106051), received between Apr 13, 2026 and Jul 15, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  LITTLE, M. W., O'GRADY, A., BRIGGS, J., GIBSON, M., SPEIRS, A., AL-REKABI, A., YOONG, P., ARIYANAYAGAM, T., DAVIES, N., TAYTON, E., TAVARES, S., MACGILL, S., MCLAREN, C., & HARRISON, R. (2024). GENICULAR ARTERY EMBOLISATION IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE (GENESIS) USING PERMANENT MICROSPHERES: LONG-TERM RESULTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 47(12), 1750-1762. HTTPS://DOI.ORG/10.1007/S00270-024-03752-7 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES ONE PATIENT UNDERGOING GAE THAT DEVELOPED A POPLITEAL DEEP VEIN THROMBOSIS (DVT) 15-DAYS POST-INTERVENTION. THE VENOUS THROMBUS WAS NOT DIRECTLY RELATED TO GAE. MOREOVER, IT WAS RELATED TO IMMOBILITY IN THE POST-OPERATIVE PERIOD. THIS COMPLICATION HIGHLIGHTS THE IMPORTANCE OF EARLY MOBILIZATION POST GAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25829662 ↗
• MalfunctionApr 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREP FOR A HEPATIC ARTERY EMBOLIZATION, A FOREIGN MATERIAL RESEMBLING A HAIR WAS FOUND IN THE SYRINGE. THIS PRODUCT WAS NOT USED FOR THE PROCEDURE. A NEW DEVICE WAS USED INSTEAD. NO INJURY OR ADDITIONAL MEDICAL TREATMENTS WERE REQUIRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964576 ↗
• MalfunctionApr 13, 2026Break

  THE CUSTOMER REPORTS THE TIP OF THE SYRINGE WAS BROKEN PRIOR TO SURGERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865378 ↗