TheraSphere Y90 Glass Microspheres 15 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05060116920321), received between Jun 16, 2017 and Feb 21, 2019 — classified as 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT. REFER TO MDR 3002124543-2019-00006 AND 3002124543-2019-00007 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 12 FEB 2019. SAE: CHOLECYSTITIS. THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) CAUCASIAN MALE SUBJECT, WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED (B)(6). ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY (IRINOTECAN). ON (B)(6) 2018, THE SUBJECT RECEIVED THE MOST RECENT CYCLE (FIRST) OF SECOND-LINE CHEMOTHERAPY, IRINOTECAN 150 MG/M^2 INTRAVENOUS (IV). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 2 VIAL (DOSE: 115.47 GY, ACTIVITY OF 15 GBQ, LOT NO 1899474091 AND 1899474092, EXPIRY DATE: 26 OCT 2018). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (DOSE: 111.89 GY, VIAL ACTIVITY OF 15 GBQ/LOT NO 1899474090, EXPIRY DATE: 26 OCT 2018). THERE IS NO RELEVANT MEDICAL HISTORY TO THE EVENT. CONCOMITANT MEDICATIONS INCLUDED ALCLOMETASON

  Patient problems: No Code Available

  MAUDE report 8357421 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT. REFER TO MDR 3002124543-2019-00006 AND 3002124543-2019-00008 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 12 FEB 2019. SAE: CHOLECYSTITIS. THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) CAUCASIAN MALE SUBJECT, WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED (B)(6). ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY (IRINOTECAN). ON (B)(6) 2018, THE SUBJECT RECEIVED THE MOST RECENT CYCLE (FIRST) OF SECOND-LINE CHEMOTHERAPY, IRINOTECAN 150 MG/M^2 INTRAVENOUS (IV). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 2 VIAL (DOSE: 115.47 GY, ACTIVITY OF 15 GBQ, LOT NO 1899474091 AND 1899474092, EXPIRY DATE: 26 OCT 2018). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (DOSE: 111.89 GY, VIAL ACTIVITY OF 15 GBQ/LOT NO 1899474090, EXPIRY DATE: 26 OCT 2018). THERE IS NO RELEVANT MEDICAL HISTORY TO THE EVENT. CONCOMITANT MEDICATIONS INCLUDED ALCLOMETASON

  Patient problems: No Code Available

  MAUDE report 8357382 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT. REFER TO MDR 3002124543-2019-00007 AND 3002124543-2019-00008 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 12 FEB 2019. SAE: CHOLECYSTITIS. THIS REPORT CONCERNS SUBJECT (B)(6), A (B)(6) CAUCASIAN MALE SUBJECT, WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED (B)(6). ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY (IRINOTECAN). ON (B)(6) 2018, THE SUBJECT RECEIVED THE MOST RECENT CYCLE (FIRST) OF SECOND-LINE CHEMOTHERAPY, IRINOTECAN 150 MG/M^2 INTRAVENOUS (IV). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 2 VIAL (DOSE: 115.47 GY, ACTIVITY OF 15 GBQ, LOT NO 1899474091 AND 1899474092, EXPIRY DATE: 26 OCT 2018). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (DOSE: 111.89 GY, VIAL ACTIVITY OF 15 GBQ/LOT NO 1899474090, EXPIRY DATE: 26 OCT 2018). THERE IS NO RELEVANT MEDICAL HISTORY TO THE EVENT. CONCOMITANT MEDICATIONS INCLUDED ALCLOMETASON

  Patient problems: No Code Available

  MAUDE report 8357315 ↗
• DeathMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR REPORT NUMBER: 3002124543-2018-00028. 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 3002124543-2018-00027 FOR THE OTHER DEVICES ASSOCIATED WITH THIS EVENT. INTERNAL MCN: (B)(4). SUBJECT# (B)(6). LAST SAE REPORT: (B)(6) 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 REGI

  Patient problems: Death; Liver Damage/Dysfunction

  MAUDE report 7497618 ↗
• DeathJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW UP REPORT TO UPDATE THE SAE TERM. NO NEW INFORMATION HAS BEEN RECEIVED. MFR REPORT NUMBER: 3002124543-2017-00029. INTERNAL MCN# (B)(4). SUBJECT# (B)(6). LAST SAE REPORT: 12 JUN 2017. UPDATE TO SAE TERM: TERMINAL LIVER FAILURE (HEPATIC FAILURE).

  Patient problems: Death; Liver Damage/Dysfunction; No Code Available

  MAUDE report 6646597 ↗