TheraStrand® with TheraSeed® XX7210SMRecalls & reported problems
Theragenics Corporation · TheraStrand with 10 seeds and 0 or spacers in Mesh · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813787020853), received between Aug 30, 2021 and Aug 30, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2021Microbial Contamination of Device
A PATIENT WAS IMPLANTED WITH THE THERAGENICS THERAMESH ON (B)(6) 2021. AN INFECTION DEVELOPED AT THE TREATMENT SITE. THERE IS A PLAN TO EXPLANT THE DEVICE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Unspecified Infection
MAUDE report 12391887 ↗
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- BrachySource™ PS1251CSBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide3 reports
- TheraSeed®, SourceCap™ TS200CSFBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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