TheraSphere Y90 Glass Microspheres 6.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060116920383), received between Jun 2, 2017 and Apr 7, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 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 ACUTE RADICULAR DUODENITIS, REQUIRING PRESCRIPTION MEDICATION. PRE-TREATMENT, ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. VASCULAR ACCESS WAS THROUGH THE FEMORAL ARTERY. 99MTC-MACROAGGREGATED ALBUMIN (MAA) INFUSION WAS PERFORMED DURING THE PRE-TREATMENT ANGIOGRAPHY. CATHETER POSITION FOR THE 99MTC-MAA INFUSION WAS LEFT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS II/III/IV). SPECT / CT WAS PERFORMED AS A POST 99MTC-MAA 3D IMAGING WHICH SHOWED SIGNIFICANTLY HIGHER OVERALL PERFUSION IN TUMOUR VERSUS NORMAL LIVER AND COMPLETE DISTRIBUTION (99MTC-MAA DISTRIBUTION IN 98-100% OF THE TUMOUR VOLUME. PRE-TREATMENT MAA DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 158 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 308 GY. ON 18-JUL-2022, THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY, AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER POSITIONING WAS LEFT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS II/III/IV): 4.736 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. POST TREATMENT DOSIMETRY DOCUMENTED AN

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Ulcer; Unintended Radiation Exposure; Vomiting

  MAUDE report 21785140 ↗
• InjuryMar 25, 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 CLINICALLY SIGNIFICANT EVENT. REFER TO MDR 3002124543-2019-00021 AND 3002124543-2019-00023 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 14 MAR 2019. SAE: LIVER FAILURE (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A MALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6). ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN 337 MG INTRAVENOUS (IV), FOLINIC ACID 749 MG IV AND FLUOROURACIL 749 MG AND 4495 MG IV WHICH COMPLETED ON (B)(6) 2019). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH TWO VIALS (LOT NO 1899055, EXPIRY DATE: 23 FEB 2018 AND 1899048, EXPIRY DATE: 16 FEB 2018) AT A DOSE OF 119.89 GY AND 110.91 GY (SEGMENT 8 ONLY). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (LOT NO 1899048, EXPIRY DATE: 16 FEB 2018) AT A DOSE OF 115.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 8447882 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE HAS BEEN ALSO REPORTED AS A USADE ASSOCIATED WITH THE IDE. 3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS CLINICALLY SIGNIFICANT EVENT. REFER TO MDR 3002124543-2018-00046 AND 3002124543-2018-00048 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR REPORT NUMBER: 3002124543-2018-00047. (B)(4). LAST SAE REPORT: 19 OCT 2018. SAE: SYMPTOMATIC NON-CIRRHOTIC PORTAL HYPERTENSION DEFINITELY RELATED TO SIRT (THERASPHERE) (NON-CIRRHOTIC PORTAL HYPERTENSION). THIS REPORT CONCERNS SUBJECT (B)(6), A MALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY(B)(6) IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN 337 MG, FOLINIC ACID 749 MG AND FLUOROURACIL 749 MG AND 4495 MG INTRAVENOUS (IV) WHICH COMPLETED ON (B)(6) 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATI

  Patient problems: No Code Available

  MAUDE report 8018333 ↗
• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT PMA/510(K) NUMBER TO H980006. .

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 6607535 ↗