TheraSphere Y90 Glass Microspheres 7 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060116920307), received between Feb 15, 2018 and Mar 19, 2025 — classified as 3 deaths, 3 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE BACK PAIN REQUIRING HOSPITALIZATION. THE PATIENT WAS ENROLLED IN AN INVESTIGATOR-INITIATED STUDY OF IMMUNOTHERAPY WITH DURVALUMAB OR DURVALUMAB AND TREMELIMUMAB, BOTH COMBINED WITH Y-90 SIRT THERAPY. THE PATIENTS HAVE ADVANCED STAGE INTRAHEPATIC BILIARY TRACT CANCER (BTC) AND RECEIVE Y-90 SIRT THERAPY AS STANDARD OF CARE. THIS PATIENT UNDERWENT SIRT WITH THERASPHERE ADMINISTRATION ON (B)(6) 2025. ON (B)(6) 2025, DURVALUMAB AND TREMELIMUMAB WERE GIVEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. THE PATIENT HAD SEVERE BACK PAIN WITH LIMITATION IN ACTIVITIES OF DAILY LIVING. THERE WAS CLINICAL WORSENING SINCE THERASPHERE ADMINISTRATION AND IMMUNOTHERAPY WITH LUMBAR PAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 21643454 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT HAD EPIGASTRIC PAIN AND A NON-OBSTRUCTIVE PULMONARY EMBOLISM, REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED IN THE CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED AVID UPTAKE IN ALL LESIONS. THERMOSPHERE TREATMENT ADMINISTRATION WAS PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2024, MONOTHERAPY OF 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2024, MONOTHERAPY OF 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. THE SUBJECT HAD EPIGASTRIC PAIN AND A NON-OBSTRUCTIVE PULMONARY EMBOLISM. THE ADVERSE EVENTS WERE TREATED WITH THE FOLLOWING MEDICATION: ACUPAN (20MG/ FOUR TIMES PER DAY, STARTING (B)(6) 2024), INNOHEP 4 000UI/0.55(1 INJECTION/ DAILY, (B)(6) 2024), AND ELIQUIS (5 MG/ TWICE DAILY, STARTING (B)(6) 2024).

  Patient problems: Abdominal Pain; Pain; Pulmonary Embolism

  MAUDE report 21369254 ↗
• DeathMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO THERASPHERE VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE DEATH OF THE SUBJECT. REFER TO MDR 3002124543-2018-00028 FOR THE OTHER DEVICES ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT# (B)(6). LAST SAE REPORT: 25 APR 2018. SAE: HEPATIC FAILURE (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A MALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A PHASE III CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2017, THE SUBJECT STARTED TO RECEIVE TREATMENT (FIRST CYCLE) WITH SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 170 MG INTRAVENOUS (IV), FOLINIC ACID 400 MG IV, AND FLUOROURACIL 4000 MG IV). THE SUBJECT RECEIVED 1 VIAL OF THERASPHERE®, VIAL ACTIVITY 15 GBQ (DOSE IN GREY WAS NOT REPORTED) TO RIGHT LOBE AND 1 VIAL OF 7 GBQ ACTIVITY OF THERASPHERE® TO THE LEFT LOBE ON (B)(6) 2017 FOR METASTATIC COLORECTAL CARCINOMA. ON (B)(6) 2018, THE SUBJECT RECEIVED MOST RECENT CYCLE PRIOR TO THE EVENT (TWELFTH CYCLE) OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 170 MG IV, FOLINIC ACID 400 MG IV, FLUO

  Patient problems: Death; Liver Damage/Dysfunction

  MAUDE report 7497617 ↗
• DeathFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE MEDICAL HISTORY, BILIRUBIN LEVELS, SUBJECT'S COURSE OF EVENT, EVENT OUTCOME, SERIOUSNESS AND SEVERITY TO DEATH, THAT THE EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE AND WAS RELATED TO DISEASE UNDER STUDY - LIVER METASTASES. MFR REPORT NUMBER: 3002124543-2018-00016. THREE THERASPHERE VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE SERIOUS INJURY. REFER TO MDR 3002124543-2018-00009 AND 3002124543-2018-00017 FOR THE OTHER DEVICES ASSOCIATED WITH THIS EVENT. INTERNAL MCN: (B)(4). SUBJECT# (B)(6). LAST SAE REPORT: (B)(6) 2018. SAE: WORSENING BILIRUBIN LEVELS (BLOOD BILIRUBIN INCREASED). THE SUBJECT'S MEDICAL HISTORY INCLUDED CANCER OF SIGMOID COLON WITH METASTASES TO LIVER. ON (B)(6) 2018, BILIRUBIN LEVEL DECREASED TO 12 MG/DL; ON (B)(6) 2018, BILIRUBIN LEVEL WAS 11.2 MG/DL. ON (B)(6) 2018, BILIRUBIN LEVEL INCREASED TO 13.1 MG/DL. ON (B)(6) 2018, BILIRUBIN LEVEL WAS 12 MG/DL AND THE PLEUREX DRAIN BEGAN TO LEAK. THE SUBJECT'S HAD 10/10 PAIN ON SCALE AND THERE WAS NO INFECTION. THE DRAIN WAS REPLACED WITH A NEW ONE ON (B)(6) 2018 WITHOUT COMPLICATIONS. THE SUBJECT COMPLETED END OF STUDY AND WAS ON LONG-T

  Patient problems: Death; Hyperbilirubinemia

  MAUDE report 7298656 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT, (B)(4) SUBJECT (B)(6), LAST SAE REPORT: (B)(6) 2018, SAE: GASTRIC PERFORATION (GASTRIC PERFORATION) THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT (B)(6) WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A (B)(6) CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ALTHOUGH, THE INFORMATION REGARDING SUBJECT RANDOMIZATION WAS NOT REPORTED ON THE SAE REPORT FORM, IT WAS CONFIRMED THAT THE PATIENT WAS RANDOMIZED TO THERASPHERE® STUDY DEVICE GROUP. THE SUBJECT RECEIVED THERASPHERE® 107 GY TO THE RIGHT LOBE AND 121 GY AND 115 GY TO THE LEFT LOBE ON (B)(6) 2017. INFORMATION REGARDING TREATMENT WITH SECOND-LINE CHEMOTHERAPY FOR METASTATIC COLORECTAL CARCINOMA WAS NOT PROVIDED. THE SUBJECT'S MEDICAL HISTORY WAS NOT REPORTED AT THE TIME OF THIS REPORT. ON (B)(6) 2018, THE SUBJECT WAS HOSPITALIZED DUE TO GASTRIC PERFORATION, GRADE 3. THE SUBJECT TREATMENT WAS NOT REPORTED AT THE TIME OF THIS REPORT. THE EVENT GASTRIC PERFORATION OUTCOME WAS NOT REPORTED AT THE TIME OF THIS REPORT. THE SUBJECT CONTINUED PARTICIPATION IN THE STUDY. THE INVESTIGATOR ASSESSED THE EVENT OF GASTRIC PERFORATION A

  Patient problems: Internal Organ Perforation; No Known Impact Or Consequence To Patient

  MAUDE report 7288229 ↗
• DeathFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). (B)(6). LAST SAE REPORT: (B)(6) 2018. SAE: WORSENING BILIRUBIN LEVELS (BLOOD BILIRUBIN INCREASED). THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) FEMALE SUBJECT, WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A (B)(6) CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2017, THE SUBJECT WAS RANDOMIZED TO RECEIVE STUDY DEVICE AND SECOND LINE CHEMOTHERAPY TREATMENT FOR METASTATIC COLORECTAL CARCINOMA. ON (B)(6) 2017, THE SUBJECT STARTED TREATMENT WITH SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN. ON (B)(6) 2017, THE SUBJECT RECEIVED TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AT 121.5 GY IN SEGMENT 5,6,7,8 OF THE RIGHT LOBE AND 120.6 GY IN SEGMENT 4 AND 120.7 GY IN SEGMENT 2 AND 3 OF THE LEFT LOBE. ON (B)(6) 2017, THE SUBJECT RECEIVED THIRD CYCLE (MOST RECENT CYCLE BEFORE THE EVENT) OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN 180 MG/M^2 X 2.36 M^2 IV (320 MG); LEUCOVORIN CALCIUM 400 MG/M^2 X 2.36 M^2 IV (712 MG) AND FLUOROURACIL 400 MG/M^2 X 2.36 M^2 IV (710 MG) AND 2400 MG/M^2 X 2.36 M^2 IV (4270 MG)). THE SUBJECT DID NOT UNDERGO ANY FURTHER CHEMOTHER

  Patient problems: Death; Hyperbilirubinemia

  MAUDE report 7272480 ↗