Embosphere® 00884450116715Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450116715), received between Jun 16, 2021 and Jul 14, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 10, 2026Open, Classified

   Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.

   Z-3305-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJul 14, 2026Fluid/Blood Leak

  CUSTOMER REPORTED THAT THERE WAS NO LIQUID IN THE SYRINGE IN THE ORIGINAL PACKAGING. THE MICROSPHERE WAS FOUND TO BE IN A DRY STATE, AND THE LIQUID LEAK WAS OBSERVED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812269 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24873400 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24870851 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24870843 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24870836 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24870835 ↗
• MalfunctionApr 14, 2026Illegible Information

  THE CUSTOMER REPORTED THE EXPIRY DATE (YEAR) ON THE PRODUCT LABEL CONFUSED THE CUSTOMER BECAUSE IT LOOKS 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 24870830 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A TUMOR EMBOLIZATION WAS PERFORMED USING EMBOLIC DEVICES WITHIN THE MIDDLE MENINGEAL ARTERY 2 DAYS BEFORE SCHEDULED CRANIOTOMY SURGERY. LATER ON A CRANIOTOMY INVOLVING THE CONTRALATERAL SIDE WAS PERFORMED, FOLLOWED BY RUMOR RESECTION (SIMPSON GRADE, II). DURAL DEFECTS WERE CLOSED WITH DURAGEN. PATHOLOGICAL DIAGNOSIS WAS TRANSITIONAL MENINGIOMA (WHO GRADE, I). NO NEW NEUROLOGICAL SYMPTOMS APPEARED, BUT SENSORY DISTURBANCE AND PARESIS IN THE LEFT UPPER AND LOWER EXTREMITIES DEVELOPED 8 DAYS AFTER SURGERY. MRI SHOWED CEREBRAL INFARCTION IN THE RIGHT PARIETAL LOBE. CEREBRAL VENOUS THROMBOSIS (CVT) WAS SUSPECTED, AND DRIP INFUSION OF HEPARIN WAS STARTED. TWELVE HOURS LATER, HOWEVER, SEIZURES OCCURRED ON THE LEFT SIDE OF THE BODY, AND MOVEMENT DISORDER (MANUAL MUSCLE TESTING, 2/5) AND SENSORY DISTURBANCE ON THE LEFT SIDE OF THE BODY, LEFT UNILATERAL SPATIAL NEGLECT AND APRAXIA DEVELOPED. MRI SHOWED THAT THE INFARCT AREA IN THE RIGHT TEMPORAL LOBE HAD BECOME HEMORRHAGIC, AND MAGNETIC RESONANCE VENOGRAPHY (MRV) REVEALED STENOSIS OF THE SUPERIOR SAGITTAL SINUS JUST BENEATH THE SITE OF CRANIOTOMY. SUPERIOR SAGITTAL SINUS THROMBOSIS WAS THUS DIAGNOSED. DRIP INFUSION O

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12013323 ↗