BrachyStar™, FastFill™ 818205Recalls & reported problems
Bard Brachytherapy, Inc. · BrachyStar FastFill Seed Implant Needle with Antistatic Plastic Hub, Bone Wax Tip Insert and Lubricious Coating, 18g x 20cm Length · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801741124119), received between Jan 11, 2025 and Jan 11, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133255 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133254 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133253 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133250 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133249 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133207 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133206 ↗MalfunctionJan 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE WAX ALLEGEDLY DISLODGED FROM THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133205 ↗
Other System, applicator, radionuclide, manual devices
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- SIROS Delivery Set SIR-10300Sirtex Medical Inc. · System, Applicator, Radionuclide, Manual9 reports
- BrachyStar™ 918205Bard Brachytherapy, Inc. · System, applicator, radionuclide, manual8 reports
- BrachyStar™ 918201Bard Brachytherapy, Inc. · System, applicator, radionuclide, manual8 reports
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- Cradle, BK 8848 6211Best Nomos · System, Applicator, Radionuclide, Manual1 report
- TheraSphere™ M00139553CEA0Boston Scientific Corporation · System, applicator, radionuclide, manual1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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