SIR-Spheres microspheres SIR-Y001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M425SIRY0010), received between Jun 17, 2019 and Dec 31, 2024 — classified as 4 deaths, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOORWAY90 CLINICAL STUDY PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, AND VOMITING. PATIENT DEVELOPED ASCITES WHICH RESULTED IN PROLONGATION OF HOSPITAL STAY.

  Patient problems: Abdominal Pain; Ascites; Vomiting

  MAUDE report 21047619 ↗
• DeathJun 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT FAMILY MEMBER STATED IN EMAIL: "WHAT HAPPENS WHEN A PATIENT DIES FROM RADIATION PNEUMONITIS DUE TO TREATMENT? THE PATIENT PASSED MAPPING PROCEDURE HOWEVER AT THE FIRST SIGN OF ADVERSE REACTIONS YOUR RESEARCHERS WENT OUT OF THEIR WAY TO DENY THE TREATMENT CAUSED ANY AILMENTS PATIENT EXPERIENCED FOR 2 MONTHS. RESEARCHERS ACTUALLY TRIED TO ARGUE CAUSE OF DEATH WITH ICU DRS TREATING THE RADIATION PNEUMONITIS. IF THEY HAD INTERVENED INSTEAD OF DENYING FROM THE FIRST SIGN OF RESPIRATORY PROBLEMS, THE PATIENT MAY STILL BE ALIVE." PATIENT FAMILY ALLEGE THAT PATIENT DIED FROM RADIATION PNEUMONITIS, FOLLOWING A SIR-SPHERES INVESTIGATIONAL PROCEDURE. THE FAMILY MEMBER DOES MENTION THAT THE IR TEAM THAT PERFORMED THE PROCEDURE DETERMINED THAT PATIENT DID NOT HAVE RADIATION PNEUMONITIS. HOWEVER, FAMILY STILL BELIEVES THAT PATIENT SUFFERED FROM THIS. PATIENT FAMILY MEMBER STATES THAT PATIENT WAS SEEN AT (B)(6) MEDICAL CENTER (B)(6) IN (B)(6) , WITH THE MAPPING PROCEDURE ON (B)(6) 2024 AND THE SIR-SPHERES PROCEDURE ON (B)(6) 2024. THE FAMILY ALSO STATES THAT DR. (B)(6) (RESIDENT) AND DR. (B)(6) (ATTENDING) WERE THE TREATING PHYSICIANS FOR THE PROCEDURES. SIRTEX ADVERSE EVENT REPORTS FROM

  Patient problems: Pneumonia; Respiratory Failure

  MAUDE report 19613314 ↗
• MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING THE ADMINISTRATION OF THE SECOND DOSE OF A SPLIT DOSE CASE OF SIR-SPHERES TREATMENT, DR. (B)(6) WAS NO LONGER ABLE TO INJECT THROUGH EITHER THE B OR D LINES. DR. (B)(6), WHO WAS PROCTORING DR. (B)(6) , WAS ALSO PRESENT AND ASSISTED IN TROUBLE SHOOTING TO ATTEMPT TO CLEAR THE LINE. THE LINE WAS PULLED AND CASE WAS COMPLETED. THE ENTIRE SYSTEM WAS SENT TO BE DECAYED. POST SURVEY SHOWED APPROXIMATELY 45% OF THE DOSE WAS DELIVERED TO PATIENT PRIOR TO CLOGGING (PRESCRIBED DOSE .3GBQ, ADMINISTERED WAS .14 GBQ). NON-SIRTEX EQUIPMENT USED WAS A SIM 2 CATHETER INTO THE CELIAC TRUNK AND 2.4FR. PROGREAT INTO THE DISTAL PORTION OF SEGMENT 7. NUC MED IS HOLDING THE SYSTEM UNTIL IT'S DECAYED TO BACKGROUND AND WILL SHIP BACK FOR QUALITY TO CHECK THE SYSTEM TO SEE IF THE ISSUE WAS THE SIROS TUBING OR A CLOGGED/KINKED MICROCATHETER. ALSO OF NOTE, INSIDE OF SIROS BOX WAS HOT TREATMENT. THE D PORT CONNECTION GOING INTO THE D-VIAL WAS CRACKED. SUSPECT DUE TO PRESSURE BUILD UP WITHIN THE SYSTEM WHEN DR. HAZELTON WAS NO LONGER ABLE TO INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826214 ↗
• MalfunctionFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE INCLUDED A SEGMENTAL DELIVERY WITH MULTIPLE ALIQUOTS. EVERYTHING PRIOR AND DURING THE PROCEDURE LOOKED NORMAL. WHEN THE POST PROCEDURE 4 POINT SURVEY WAS DONE THE HEALTHCARE PROFESSIONAL REALIZED THAT ONLY 40% OF THE PRESCRIBED DOSE WAS DELIVERED TO THE PATIENT. NO FURTHER INFORMATION HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788562 ↗
• InjuryOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT THREE SESSIONS OF TACE AND ONE SESSION OF Y90. ROUTINE IMAGING SURVEILLANCE WAS PERFORMED FOLLOWING EACH THERAPY SESSION. NO SIGNIFICANT CHANGES TO TUMOR SIZE WERE NOTED. DEVELOPMENT OF ABSCESS AND SEPSIS WITHIN THE TREATED TUMOR WAS SEEN. FOLLOWING Y90, PATIENT UNDERWENT MULTIPLE PERCUTANEOUS DRAINAGE PROCEDURES. PATIENT CONDITION DETERIORATED AND THE FAMILY DECIDED AGAINST FURTHER INTERVENTIONS.

  Patient problems: Abscess; Sepsis

  MAUDE report 17996860 ↗
• DeathMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIRTEX'S SALES REPRESENTATIVE SPOKE WITH DR. CHO ON FRIDAY, APRIL 7 REGARDING AN ADVERSE EVENT THAT OCCURRED WITH A PATIENT THAT WAS TREATED ON (B)(6) 2023. PATIENT WAS PRESCRIBED 3.663 GBQ'S TO SEGMENT 5 OF THE RIGHT LOBE, TUMOR VOLUME WAS 16CC'S. PATIENT DEVELOPED ABDOMINAL PAIN POST TREATMENT WHICH PROGRESSED TO FURTHER COMPLICATIONS AFTER THE TREATMENT. PATIENT DIED 5-6 WEEKS LATER FROM SEPSIS WHICH ORIGINATED IN THE ANTERIOR PORTION OF THE RIGHT LOBE.

  Patient problems: Sepsis

  MAUDE report 16875496 ↗
• DeathDec 22, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRE-EXISTING ISSUE WITH ULCERS. PATIENT TREATED WITH SIR-SPHERES ON (B)(6) 2019, AND EXPERIENCED GASTRIC ULCER AFTER THE PROCEDURE. PATIENT PASSED AWAY ON (B)(6) 2019. WE REQUESTED ADDITIONAL INFORMATION FROM THE PHYSICIAN AND HAVE NOT OBTAINED ANY FURTHER DETAILS.

  Patient problems: Death; Ulcer

  MAUDE report 9508723 ↗
• DeathDec 17, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED WITH SIR-SPHERES ON (B)(6) 2019. THE PATIENT HAD A FEW LINES OF CHEMOTHERAPY. 10 DAYS AFTER THE PROCEDURE THE PATIENT WAS ADMITTED AND HIS DISEASE HAD METASTASIZED. DATE OF DEATH WAS (B)(6) 2019 AT 14:36PM. SPOKEN WITH VP OF (B)(6), PER THEIR RISK MANAGEMENT DEPARTMENT, THEY CANNOT PROVIDE US WITH A NARRATIVE OR ANY DETAILS SURROUNDING THE PATIENT'S DEATH.

  Patient problems: Death

  MAUDE report 9478748 ↗
• InjuryNov 3, 2019Obstruction of Flow; Physical Resistance/Sticking

  DURING INFUSION RESISTANCE WAS MET WHEN CONTRAST WAS INJECTED TO INFUSE SIR-SPHERES INTO PATIENT. TUBING DISCONNECTED FROM MICROCATHETER AND ATTEMPT IS MADE TO FLUSH MICROCATHETER WHICH WAS AGAIN MET WITH RESISTANCE. MICROCATHETER AND GUIDEWIRE WERE REMOVED AND NEW 2.9 FRENCH MICROCATHETER WAS INSERTED. CASE COMPLETED. THIS INCIDENT WAS NOT CAUSE BY SIR-SPHERES, HOWEVER AS THE RESULT OF THIS CATHETER CLOGGING - 14.42 MCI'S WAS ADMINISTERED AND 21.2 MCI'S WERE DRAWN. SO ONLY 68% OF THE DOSE WAS ADMINISTERED TO PATIENT.

  Patient problems: Underdose

  MAUDE report 9270716 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT WITH PRIMARY HCC UNDERWENT SIRT TREATMENT OF RIGHT LOBE (1.48 GBQ) ON (B)(6) 2019. APPROXIMATELY 2 WEEKS AFTER SIRT TREATMENT PATIENT PRESENTED WITH DIFFUSE RASH (FACE, CHEST AND BACK) THAT REQUIRED TREATMENT (GRADE 2). PRESCRIBED TREATMENT INCLUDED: MEDROL DOSE PACK, PROTONIX, ZANTAC, OXYCODONE AND ZOFRAN.

  Patient problems: Rash

  MAUDE report 8704224 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT WITH MCRC UNDERWENT SIRT TREATMENT OF RIGHT LOBE (1.17 GBQ) ON (B)(6) 2019. AFTER SIRT TREATMENT PATIENT PRESENTED WITH DIFFUSE RASH (FACE, CHEST AND BACK) THAT REQUIRED TREATMENT (GRADE 2). PRESCRIBED TREATMENT INCLUDED: MEDROL DOSE PACK, PROTONIX, ZANTAC, OXYCODONE AND ZOFRAN.

  Patient problems: Rash

  MAUDE report 8704223 ↗