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TheraSeed® TS200CNRecalls & reported problems

Bard Brachytherapy, Inc. · Model 200 TheraSeed® Palladium-103 in Cartridges with Preloaded Needles · 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 00801741078422), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected1
  • Inadequate Instructions for Healthcare Professional1

Patient problems

  • No Consequences Or Impact To Patient1
  • 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 17, 2018Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Device Operates Differently Than Expected

    IT WAS REPORTED THAT THE SEEDS WERE SHIPPED TO GOOD SHEPHERD MEDICAL CENTER INSTEAD OF LONGVIEW REGIONAL MEDICAL CENTER IN (B)(4). THE COMPLAINANT REPORTEDLY ORDERS PRODUCTS FOR EACH OF THESE FACILITIES. THE SEEDS WERE THEN SHIPPED TO THE CORRECT FACILITY OVERNIGHT AND WERE DELIVERED IN TIME FOR THE SCHEDULED IMPLANT. THE PATIENT REPORTEDLY RECEIVED THE FULL PRESCRIBED DOSE.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7524570 ↗

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.