TheraSeed®, SourceCap™ TS200CSFRecalls & reported problems
Bard Brachytherapy, Inc. · Model 200 TheraSeed® Palladium-103 in Cartridges with SourceCap™ Endcaps · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741078439), received between Sep 29, 2025 and Sep 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT A BRACHYTHERAPY PROCEDURE USING BRACHYTHERAPY IMPLANT NEEDLES. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS AN OBSTRUCTION OCCURRED IN THE MICK APPLICATOR SYSTEM WHICH RESULTED IN BLOCKAGE, LEADING TO THE TERMINATION OF THE PROCEDURE. REPORTEDLY THERE WAS A DELAY IN SURGERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23164488 ↗MalfunctionSep 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT A BRACHYTHERAPY PROCEDURE USING BRACHYTHERAPY IMPLANT NEEDLES. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS AN OBSTRUCTION OCCURRED IN THE MICK APPLICATOR SYSTEM WHICH RESULTED IN BLOCKAGE, LEADING TO THE TERMINATION OF THE PROCEDURE. REPORTEDLY THERE WAS A DELAY IN SURGERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23164449 ↗MalfunctionSep 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT A BRACHYTHERAPY PROCEDURE USING BRACHYTHERAPY IMPLANT NEEDLES. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS AN OBSTRUCTION OCCURRED IN THE MICK APPLICATOR SYSTEM WHICH RESULTED IN BLOCKAGE, LEADING TO THE TERMINATION OF THE PROCEDURE. REPORTEDLY THERE WAS A DELAY IN SURGERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23164405 ↗
Other Source, brachytherapy, radionuclide devices
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- QuickLink™, SourceLink™ 70303QC20Bard Brachytherapy, Inc. · Source, brachytherapy, radionuclide7 reports
- QuickLink™, BrachySource™ 1251QCSBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide5 reports
- GammaTile™ GT-001Gt Medical Technologies, Inc. · Source, Brachytherapy, Radionuclide5 reports
- BrachySource™ PS1251LSBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide4 reports
- QuickLink™, BrachySource™ 1251QCLBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide4 reports
- BrachySource™ PS1251CSBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide3 reports
- BrachySource™ 1251CSRBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.