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TheraSeed® TS200CRecalls & reported problems

Bard Brachytherapy, Inc. · Model 200 TheraSeed® Palladium-103 in Cartridges · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741078408), received between May 26, 2017 and May 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Missing1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2017Component Missing

    IT WAS REPORTED THAT THERE WAS NO INDEPENDENT ASSAY PROVIDED WITH THE SEEDS. IT WAS ALSO REPORTED THAT THE PATIENT DECIDED TO ABANDON BRACHYTHERAPY TREATMENT ALL TOGETHER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6594178 ↗

Other Source, brachytherapy, radionuclide devices

All Source, brachytherapy, radionuclide devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.