TheraSphere Administration Set 990226.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920253), received between Oct 20, 2021 and Aug 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Radiation Underexposure” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 23, 2021Class IIOpen, Classified

   Potential for leaks and loosening at the patient catheter connection

   Z-2327-2021 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Contamination; Device Contamination with Chemical or Other Material; Radiation Underexposure; Contamination; Device Contamination with Chemical or Other Material; Radiation Underexposure

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS OBSERVED IN THE TUBING. TWO THERASPHERE ADMINISTRATION SETS WERE SELECTED FOR USE IN THE DELIVERY OF 6.5GBQ AND 10.5 GBQ THERASPHERE DOSE VIALS IN A Y-90 PROCEDURE. DURING THE FIRST ADMINISTRATION, ALL THE PROPER STEPS WERE FOLLOWED OFF THE CHECKLIST; HOWEVER, WHEN INJECTING, THE PRESSURE VIAL IMMEDIATELY STARTED TO FILL AND A BROWN GLOB WAS OBSERVED WORKING ITS WAY THROUGH THE TUBING. THE PHYSICIAN CONTINUED FLUSHING UNTIL THE RADOS DOSIMETER REACHED 0.0 MR/H. BEFORE INJECTING THE SECOND DOSE INTO ANOTHER SEGMENT OF THE LIVER, THE NON-BOSTON SCIENTIFIC MICROCATHETER WAS CHECKED FOR KINKS, BUT NONE WERE OBSERVED. THE CHECKLIST WAS FOLLOWED AGAIN FOR THE SECOND DOSE ADMINISTRATION, BUT THE SAME THING HAPPENED; HOWEVER, THIS TIME A GRAY/BLACK SPECK WAS OBSERVED WORKING ITS WAY THROUGH THE TUBING. THERE WAS A CLOUDY RESIDUE IN THE TUBING AFTER EACH ADMINISTRATION, NEAR THE NEEDLE INJECTOR. THERE WAS A LOW PERCENT DELIVERY OF 86% FOR BOTH DOSES. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787426 ↗
• MalfunctionAug 12, 2025Device Contamination with Chemical or Other Material; Radiation Underexposure; Device Contamination with Chemical or Other Material; Radiation Underexposure

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS OBSERVED IN THE TUBING. TWO THERASPHERE ADMINISTRATION SETS WERE SELECTED FOR USE IN THE DELIVERY OF 6.5GBQ AND 10.5 GBQ THERASPHERE DOSE VIALS IN A Y-90 PROCEDURE. DURING THE FIRST ADMINISTRATION, ALL THE PROPER STEPS WERE FOLLOWED OFF THE CHECKLIST; HOWEVER, WHEN INJECTING, THE PRESSURE VIAL IMMEDIATELY STARTED TO FILL AND A BROWN GLOB WAS OBSERVED WORKING ITS WAY THROUGH THE TUBING. THE PHYSICIAN CONTINUED FLUSHING UNTIL THE RADOS DOSIMETER REACHED 0.0 MR/H. BEFORE INJECTING THE SECOND DOSE INTO ANOTHER SEGMENT OF THE LIVER, THE NON-BOSTON SCIENTIFIC MICROCATHETER WAS CHECKED FOR KINKS, BUT NONE WERE OBSERVED. THE CHECKLIST WAS FOLLOWED AGAIN FOR THE SECOND DOSE ADMINISTRATION, BUT THE SAME THING HAPPENED; HOWEVER, THIS TIME A GRAY/BLACK SPECK WAS OBSERVED WORKING ITS WAY THROUGH THE TUBING. THERE WAS A CLOUDY RESIDUE IN THE TUBING AFTER EACH ADMINISTRATION, NEAR THE NEEDLE INJECTOR. THERE WAS A LOW PERCENT DELIVERY OF 86% FOR BOTH DOSES. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787425 ↗
• MalfunctionOct 20, 2021Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Radiation Underexposure; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Radiation Underexposure

  IT WAS REPORTED THAT A PROCEDURAL RELATED DISSECTION OCCURRED. IN (B)(6) 2020, A MISADMINISTRATION OF THERASPHERE Y-90 MICROSPHERES OCCURRED. THE PHYSICIAN WAS UNABLE TO INJECT THE THERASPHERE FROM THE DELIVERY APPARATUS INTO THE PATIENT. SEVEN DAYS LATER, A REPEAT PROCEDURE WAS ATTEMPTED, HOWEVER, THE INJECTION ATTEMPT FAILED. DURING THIS PROCEDURE, STENOSIS IN THE FEMORAL ARTERY WAS IDENTIFIED. THE PATIENT WAS GIVEN BLOOD THINNERS. THE STENOSIS IS THOUGHT TO BE EITHER THE DISSECTION OF THE ARTERIAL WALL FROM THE NON-BSC CLOSURE DEVICE, OR IT WAS THE DISPLACED CLOSURE DEVICE ITSELF FROM THE FIRST THERASPHERE PROCEDURE. IN LATE (B)(6) 2020, THE PATIENT REPORTED DIFFICULTY IN WALKING, THEIR LEG WOULD GO NUMB AND ESSENTIALLY FEEL DEAD AND HEAVY. THE PATIENT SOUGHT MEDICAL ADVICE. AFTER IMAGING OF THE ARTERY WAS COMPLETED, THE PATIENT LEARNED THAT THE CLOSURE DEVICE HAD COLLAPSED INTO THE ARTERY AND THE ARTERIAL WALL SUFFERED A DISSECTION. IN (B)(6) 2021, A SURGEON WHO SPECIALIZES IN ARTERIAL SURGERY ATTEMPTED TO REPAIR THE DISSECTED ARTERIAL WALL AND REMOVE THE COLLAPSED ANGIOSEAL DEVICE, HOWEVER, THE PATIENT STILL EXPERIENCES LEG NUMBNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12668230 ↗