Prostate Stabilization Set 500118200Recalls & reported problems
Argon Medical Devices, Inc. · Prostate Stabilization Set 18ga x 20cm · Class 1
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 00886333004393), received between Nov 30, 2025 and Nov 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2025Break; Break
A CUSTOMER REPORTED "THE BARB COULD NOT BE PUSHED BACK COMPLETELY. THE NEEDLE HAD TO BE REMOVED FROM THE PATIENT USING A SCALPEL. THIS INEVITABLY RESULTED IN TISSUE DAMAGE TO THE PATIENT. ONLY ONE NEEDLE FROM THE PACKAGE WAS AFFECTED. THE PRODUCT WAS DISPOSED OF." PHOTOS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23677430 ↗
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
- BrachyStar™, FastFill™ 818205Bard Brachytherapy, Inc. · System, applicator, radionuclide, manual8 reports
- 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 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.
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