Embosphere® 00884450403440Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884450403440), received between Feb 14, 2020 and Jul 16, 2026 — classified as 1 death, 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Fluid/Blood Leak; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841917 ↗
• MalfunctionJun 20, 2026Leak/Splash

  THE CUSTOMER REPORTED THE SYRINGE WAS DEFECTIVE. SOME OF THE EMBOLICS WERE COMING OUT OF ONE OF THE SYRINGES WHEN THEY OPENED THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571571 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT UPON OPENING THE DEVICE, THEY FOUND DRIED EMBOSPHERE AT THE TIP OF THE SYRINGE AND THEY ARE UNSURE IF THERE WAS LEAKAGE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334320 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CAP WAS LOOSE AND THE BEADS HAD LEAKED INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334319 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGE WAS OPENED ON A STERILE TABLE, AND THE TEAM NOTICED THE SYRINGE WAS ONLY HALFWAY FILLED. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334317 ↗
• MalfunctionMay 29, 2026Fracture

  THE CUSTOMER REPORTED THAT DURING AN EMBOLIZATION, ONE OF THE SYRINGES HAD A BROKEN LUER LOCK CONNECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334316 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN SETTING UP FOR A CASE, THE SYRINGE WAS LEAKING AND HAD NO FLUID INSIDE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334314 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, DURING PREPARATION, THE SYRINGE WAS STILL IN ITS PACKAGING, APPEARED HALF EMPTY, CONTAINED AIR, AND SEEMED TO BE DRIED OUT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334313 ↗
• MalfunctionApr 16, 2026Crack; Leak/Splash

  THE CUSTOMER REPORTS THE UNIT IS MISSING THE LIQUID, APPARENTLY IT HAS LEAKED OR EVAPORATED, LEAVING ONLY THE DRY PARTICLES. NO PATIENT INVOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905175 ↗
• MalfunctionApr 13, 2026Leak/Splash

  THE CUSTOMER REPORTED THE SYRINGE WITH THE EMBOLIZING AGENT CAME WITHOUT THE SUSPENSION LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861033 ↗
• DeathOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT IN (B)(6) 2017, AFTER A UTERINE ARTERY EMBOLIZATION PROCEDURE WHERE EMBOLICS WERE USED, THE PATIENT DIED. DEATH CAUSED BY ACUTE RIGHT HEART FAILURE DUE TO PULMONARY INFARCTION DURING UAE (UTERINE ARTERY EMBOLIZATION) PROCEDURE.

  Patient problems: Bradycardia; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Pulmonary Infarction

  MAUDE report 15638439 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT WITH HEPATOCELLULAR CARCINOMA [HCC] WITHOUT CIRRHOSIS WAS ADMITTED FOR PLANNED TRANSARTERIAL CHEMOEMBOLIZATION (TACE) OF THE RIGHT LOBE & MEDIAL LEFT LOBE DETERMINED TO BE TOO ADVANCED FOR SURGICAL RESECTION OR TRANSPLANT. THE PATIENT HAD A LARGE LIVER-LUNG SHUNT PREVENTING RADIOEMBOLIZATION TREATMENT. THE IR PHYSICIAN PLACED TWO VIALS OF LC BEADS CONTAINING DOXORUBICIN AND ADMINISTERED BLAND TRANSARTERIAL EMBOLIZATION (TAE) WITH EMBOSPHERES [EMBOLIC] INTO THE RIGHT HEPATIC ARTERY. POST-PROCEDURE THE PATIENT DEMONSTRATED AN ACUTE DROP IN HEMOGLOBIN [HGB]. COMPUTED TOMOGRAPHY ANGIOGRAPHY [CTA] REVEALED MULTIPLE AREAS OF ACTIVE BLEEDING WITHIN THE LIVER AND THE FORMATION OF A NEW HEMATOMA. THE IR PHYSICIAN PERFORMED A COMPLETE EMBOLIZATION OF THE RIGHT HEPATIC ARTERY USING COILS AND GELFOAM TO ACHIEVE HEMOSTASIS. THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION AND RECEIVED BLOOD PRODUCTS AND CONTINUOUS BLOOD LAB MONITORING. THE LATTER DEMONSTRATED HYPERKALEMIA OF 5.5 MMOL/L, PREVIOUSLY NORMAL. CREATININE INCREASED FROM 0.55MG/DL TO 1.23, THOUGHT TO BE MULTIFACTORIAL. ADDITIONAL WORKUP REVEALED URIC ACID OF 12.5MG/DL, CALCIUM 6.9MG/DL & PHOSP

  Patient problems: Blood Loss

  MAUDE report 9767424 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST-UTERINE ARTERY EMBOLIZATION (UAE), THE PATIENT DEVELOPED A PERIMETRITIC INFECTION. THE PATIENT WAS TREATED FOR A 8.4×11×13 CM INTERSTITIAL MYOMA WITH EXTENSIVE ENDOMETRIAL CONTACT AND DISCHARGED TO HOME 3 DAYS POST-UAE. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN AND PYREXIA. PERIMETRITIS WAS DIAGNOSED AND ANTIBIOTIC THERAPY WAS ADMINISTERED. MYOMA EXPULSION WAS NOTED TWO DAYS LATER WHEN IT PROLAPSED FROM THE VAGINA AND WAS REMOVED. AT THE TIME OF THIS REPORT, THE PATIENT IS ONE YEAR POST-UAE, REMAINS ASYMPTOMATIC, AND THE UTERINE WAS REPORTED TO HAVE BEEN SUCCESSFULLY PRESERVED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9713755 ↗

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-