Embosphere® 00884450098561Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450098561), received between Apr 9, 2026 and Jun 2, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS DURING THE PRE-PROCEDURE A LEAKAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364671 ↗
• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS THE LIQUID INSIDE THE SYRINGE IS LEAKING. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS NOT USED ON THE PATIENT, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363745 ↗
• MalfunctionJun 2, 2026Material Integrity Problem

  THE CUSTOMER REPORTED THE MICROSPHERES AREN'T SUSPENDED IN SALINE AND IN A DRY STATE. THE PRODUCT WAS NOT USED ON THE PATIENT AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363744 ↗
• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS DURING A PREOPERATIVE EXAMINATION REVEALED THAT THERE WAS TOO LITTLE MICROSPHERE PROTECTIVE FLUID. THE SURGEON WAS WORRIED THAT THE ASEPTIC STATE WOULD BE DISRUPTED. THE PRODUCT WAS NOT USED ON THE PATIENT, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363732 ↗
• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS LEAKAGE OF FLUID WAS FOUND UPON OPENING THE PACKAGE. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363730 ↗
• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS THE SALINE HAD LEAKED FROM THE EMBOLIC MICROSPHERES WHEN THE PRODUCT WAS OPENED AND THE LIQUID VOLUME HAD DECREASED. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363726 ↗
• MalfunctionApr 9, 2026Leak/Splash

  THE CUSTOMER REPORTS THERE WAS A FLUID LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829910 ↗
• MalfunctionApr 9, 2026Leak/Splash

  THE CUSTOMER REPORTS THAT DURING THE PREOPERATIVE EXAMINATION, IT WAS FOUND THAT THE FLUID FOR EMBOLIC MICROSPHERES WAS INSUFFICIENT, AND THERE WAS CONCERN ABOUT LEAKAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829908 ↗