TheraSphere Y90 Glass Microspheres 12.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920482), received between Jun 23, 2017 and Mar 3, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020 COMPANY MEDICAL SPECIALIST OBSERVED THERASPHERE TREATMENT. THEY REPORTED "THE SYSTEM WAS SET UP CORRECTLY AND THE MICROCATHETER WAS POSITIONED IN THE LEFT HEPATIC ARTERY. THE ADMINISTRATION OF THE THERAPY WAS NORMAL. HOWEVER, THE PET IMAGES ACQUIRED AFTER THE TREATMENT SHOWED NO CONCORDANCE WITH THE PREVIOUS WORK UP IMAGE (SPECT) AS AN IMPORTANT PART OF THE ACTIVITY WAS OUTSIDE THE LIVER. THE POSSIBLE CAUSE COULD BE DUE TO VASOSPASM OF THE HEPATIC ARTERY. THE PATIENT IS RECEIVING PROPHYLACTIC TREATMENT WITH ONDANSETRON AND ANALGESIA AND IS UNDER OBSERVATION AND THE ARE GOING TO REPEAT THE PET ACQUISITION TODAY." TREATMENT INFORMATION: DATE OF THERASPHERE: (B)(6) 2020, DOSE VIALS ORDERED (GBQ) = 12, DOSE PRESCRIBED (GY)=120, ACTIVITY INFUSED (GBQ)= 0.74 GBQ, ACTUAL DOSE PATIENT RECEIVED (AFTER RESIDUAL MEASURED) (GY) 123, LOT NUMBER OF THE DEVICE - NO INFORMATION. PHYSICIAN RESPONSE TO QUESTIONS: RESULTS OF POST MAA IMAGING, WAS THERE ANY DEPOSIT OF MAA IN THE [ORGAN] = NONE. DID THE RADIOLOGIST USE COILS DURING PRE TREATMENT ANGIOGRAPHY = NONE. WHAT IS THE ORIGIN OF THE CYSTIC ARTERY, RIGHT HEPATIC ARTERY, GASTRODUODENAL ARTERY, PROPER HEPATIC ARTERY, LEFT HEPATIC AR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9778655 ↗
• DeathJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR # 3002124543-2017-00033. INTERNAL MCN: (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: 05 JUN 2017. SAE HEPATIC DECOMPENSATION (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) CAUCASIAN MALE WHO WAS ENROLLED IN STUDY TS-103 ENTITLED "A PHASE III CLINICAL TRIAL OF INTRA-ARTERIAL THERASPHERE® IN THE TREATMENT OF PATIENTS WITH UNRESPECTABLE HEPATOCELLULAR CARCINOMA (HCC). ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® FOR HEPATOCELLULAR CARCINOMA WITH DOSE OF 87 GY TO THE RIGHT LOBE. LIVER DOSE HAS BEEN REDUCED TO 87 GY TO BRING LUNG DOSE TO BELOW 30 GY AND THE SUBJECT RECEIVED ESTIMATED LUNG RADIATION EXPOSURE OF 27.6 GY. FOLLOWING STUDY DEVICE WORK-UP ON (B)(6) 2016, THE SUBJECT WAS SCHEDULED TO RECEIVE TREATMENT TO THE LEFT LOBE BUT DID NOT RECEIVE STUDY DEVICE AS HE HAD WITHDRAWN HIS INFORMED CONSENT ON (B)(6) 2016. THE SUBJECT HAD NOT RECEIVED TREATMENT WITH STANDARD OF CARE THERAPY (SORAFENIB). RELEVANT MEDICAL HISTORY INCLUDED CIRRHOSIS, HEPATOCELLULAR CARCINOMA, HEPATITIS C, ASCITES AND VARICES. CONCOMITANT MEDICATIONS INCLUDED LISINOPRIL, OMEPRAZOLE, METROFMIN, AMLODIPINE, PROPANOLOL, NOVORAPID, VARDENAFIL, LANTUS INSULIN, I

  Patient problems: Death; Liver Damage/Dysfunction

  MAUDE report 6663572 ↗