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TheraSphere Administration Set OTT-SPE-FP-001Recalls & reported problems

Biocompatibles Uk Ltd · Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres · Class 3

All models of TheraSphere Administration Set (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920635), received between Dec 2, 2020 and Dec 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 FDA recall records name this device's identifier, 2 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. Sep 26, 2023Class IIOpen, 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, 2021Class IIOpen, Classified

    Potential for leaks and loosening at the patient catheter connection

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

Most reported problems

Device problems

  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • 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 ↗

Other Microspheres Radionuclide devices

All Microspheres Radionuclide devices →

Sources and updates

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