TheraSphere Administration SetRecalls & reported problems across all models

We found 2 models of TheraSphere Administration Set by Biocompatibles Uk Ltd in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2020 and Aug 12, 2025 — classified as 5 malfunctions.

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

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TheraSphere Administration Set recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 26, 2023Open, Classified

   Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

   Z-0133-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Jul 23, 2021Open, Classified

   Potential for leaks and loosening at the patient catheter connection

   Z-2328-2021 · Root cause: Component change control · Recall details · FDA record ↗

3. Jul 23, 2021Open, 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 TheraSphere Administration Set problems

TheraSphere Administration Set models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TheraSphere Administration Set OTT-SPE-FP-001

  Microspheres Radionuclide
  2 recalls2 reports
• TheraSphere Administration Set 990226.SPE

  Microspheres Radionuclide
  1 recall3 reports

Recent TheraSphere Administration Set adverse event reports

The 5 most recent reports across all models, 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 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TREATING PHYSICIAN REPORTED THAT TWO ADMINISTRATION SETS WERE PERSISTENTLY UNWINDING AT THE CONNECTION SITE BETWEEN THE MICROCATHETER AND THE ADMINISTRATION SET DURING A PATIENT CASE. NO LEAKAGE OR CONTAMINATION OF MICROSPHERES OUTSIDE THE ADMINISTRATION SET AND CATHETER WAS REPORTED. THE USER RE-TIGHTENED THE CONNECTION, AND ALLOWED THE TUBING TO RELAX TO TEST THE CONNECTION. THIS WAS REPEATED UNTIL NO MOVEMENT WAS OBSERVED AT THE CONNECTION SITE. THE TUBING WAS NOTED TO RETAIN SOME OF THE TORQUE MEMORY TO OVERCOME THE TIGHTENED CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972532 ↗
• MalfunctionDec 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TREATING PHYSICIAN REPORTED THAT A MICROCATHETER PERSISTENTLY DETACHED FROM THE ADMINISTRATION SET DURING A PATIENT CASE, RESULTING IN A MAJOR SPILL OF THERASPHERE MICROSPHERES AT THE SITE OF CONNECTION BETWEEN THE THERASPHERE ADMINISTRATION SET AND THE MICROCATHETER. THE SPILL CONTAMINATED THE DRAPE, TOWELS, FLOOR AND SURROUNDING AREA OF THE OPERATING ROOM. THE SPILL REACHED THE SHOES OF THE ATTENDING STAFF, AS WELL AS THE GLOVES OF THE TREATING PHYSICIAN. THE TREATING OPERATING ROOM WAS SHUT DOWN FOR THE REMAINDER OF THE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932400 ↗