Embosphere® 00884450098424Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450098424), received between Apr 8, 2026 and Jun 2, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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. How this data works · Data updated Oct 13, 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, 2026Crack; Leak/Splash

  THE CUSTOMER REPORTS DURING PRE-PROCEDURE, THE TIP WAS FOUND LEAKING FLUID AFTER 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 25366130 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT BEFORE THE OPERATION, IT WAS FOUND THAT THE FLUID IN THE MICROSPHERES WAS INSUFFICIENT, AND THERE WERE CONCERNS ABOUT LEAKAGE AND THE DESTRUCTION OF THE ASEPTIC STATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365804 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  THE CUSTOMER REPORTS DURING THE INJECTION PROCESS, THE SPIRAL MOUTH OF THE SYRINGE WAS DISCONNECTED, AND THE PRODUCT COULD NOT BE USED. 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 25364672 ↗
• MalfunctionJun 2, 2026Leak/Splash

  THE CUSTOMER REPORTS DURING PRE-PROCEDURE, FLUID LEAKAGE FOUND IN SEALED PACKAGE. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363731 ↗
• MalfunctionApr 16, 2026Crack; Leak/Splash

  THE CUSTOMER REPORTS DURING PRE-PROCEDURE, THE TIP WAS FOUND LEAKING FLUID. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899020 ↗
• MalfunctionApr 13, 2026Break

  THE CUSTOMER REPORTS WHEN THE MICROCATHETER WAS USED IN SURGERY, THE LUER JOINT BETWEEN THE SYRINGE WITH THE WHITE BALL WAS REMOVED AND AT THE END OF THE SYRINGE WAS BROKEN INSIDE. THIS RESULTED IN THE FAILURE OF THE MICROCATHETER IN BEING USED. THE WHITE BALLS IN USE WERE NOT FULLY USED TO ACHIEVE THE IDEAL EMBOLIZATION EFFECT. CLINICIANS OPENED A NEW MICROCATHETER AND FILLED THE WHITE BALLS IN THE NEW SYRINGE TO COMPLETE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860912 ↗
• MalfunctionApr 8, 2026Leak/Splash; Damaged Thread

  THE CUSTOMER REPORTS THAT DURING A ARTERIAL EMBOLIZATION PROCEDURE, WHEN THE OUTER PACKAGING OF THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE SCREW THREAD WAS LOOSE AND THERE WAS LEAKAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820945 ↗
• MalfunctionApr 8, 2026Unsealed Device Packaging

  THE CUSTOMER REPORTED THAT WHEN PREPARING TO GO TO THE SURGICAL STERILE TABLE, IT WAS FOUND THAT THE PACKAGING FOR THE STERILE PRODUCT WAS NOT SEALED AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820063 ↗