Proxcelan™ Cs-131 Brachytherapy SeedsRecalls & reported problems
Isoray Medical, Inc. · Class 2 · Implant
Data updated Oct 13, 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 M748CS10), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2019Patient-Device Incompatibility
DURING A CUSTOMER SERVICE FOLLOW-UP WITH THE FACILITY, 22 DAYS POST IMPLANT, ISORAY WAS NOTIFIED THAT THE PATIENT "GOT PROCTITIS AND A COLORECTAL SURGEON DIVERTED HER WITH A COLOSTOMY." WHILE CLARIFYING IF THE ISSUE HAD CONNECTION TO THE IMPLANT, THE FACILITY SUGGESTED THAT THE TEMPORAL COURSE OF THE COMPLICATION SUGGESTS THAT THE IMPLANT WAS ASSOCIATED WITH THE DEVELOPMENT OF THE ADVERSE EVENT.
Patient problems: Inflammation
MAUDE report 9284730 ↗
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
- 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
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page