GammaTile™ GT-001Recalls & reported problems
Gt Medical Technologies, Inc. · Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00860000064507), received between Nov 5, 2020 and Mar 27, 2023 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Post Operative Wound Infection2
- Necrosis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED RADIATION NECROSIS APPROXIMATELY 2 MONTHS POST IMPLANT WHICH REQUIRED MEDICAL INTERVENTION.
Patient problems: Necrosis
MAUDE report 16624905 ↗MalfunctionMar 13, 2023Material Integrity Problem; Material Integrity Problem
DURING THE IMPLANTATION OF ORDER: (B)(4) AT (B)(6) HOSPITAL, ONE OF EIGHT TILES DEMONSTRATED PARTIAL DELAMINATION OF THE TOP (I.E. SMOOTH) LAYER OF COLLAGEN. THE DELAMINATION EXPOSED THE VICRYL SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16534897 ↗MalfunctionMar 13, 2023Material Integrity Problem; Material Integrity Problem
DURING THE IMPLANTATION OF ORDER: (B)(4) AT (B)(6) HOSPITAL, THREE OF FOURTEEN TILES DEMONSTRATED PARTIAL DELAMINATION OF THE TOP (I.E. SMOOTH) LAYER OF COLLAGEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16534896 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem
3 WEEKS POST-IMPLANTATION THE PATIENT HAD TO UNDERGO REMOVAL OF THE GAMMATILES DUE TO AN INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 10797264 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem
7 WEEKS POST- IMPLANTATION THE PATIENT HAD TO UNDERGO REMOVAL OF THE GAMMATILES DUE TO AN INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 10797260 ↗
Other Source, Brachytherapy, Radionuclide devices
- QuickLink™, SourceLink™ 70302QC10Bard Brachytherapy, Inc. · Source, brachytherapy, radionuclide10 reports
- QuickLink™, SourceLink™ 70303QC20Bard Brachytherapy, Inc. · Source, brachytherapy, radionuclide7 reports
- QuickLink™, BrachySource™ 1251QCSBard Brachytherapy, 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
- TheraSeed®, SourceCap™ TS200CSFBard Brachytherapy, Inc. · Source, brachytherapy, radionuclide3 reports
- TheraSleeve® with I-Seed XX992xiTheragenics Corporation · Source, Brachytherapy, Radionuclide2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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