Breast Localization Needles 252125Recalls & reported problems
Argon Medical Devices, Inc. · Hawkins™ II FlexStrand™ BLN 20ga x 12.5cm · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333003846), received between May 13, 2025 and May 13, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
REPORTER STATED "WHEN WE PARK THE ARGON WIRE IN PETIENT & REMOVE THE NEEDLE IN SAME PETIENT THE WIRE IS STUCK INSIDE NEEDLE & CAME OUT THE NEEDLE."
Patient problems: Insufficient Information
MAUDE report 22012771 ↗InjuryMay 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
REPORTER STATED "WHEN WE PARK THE ARGON WIRE IN PATIENT & REMOVE THE NEEDLE IN SAME PATIENT THE WIRE IS STUCK INSIDE NEEDLE & CAME OUT THE NEEDLE."
Patient problems: Insufficient Information
MAUDE report 22012584 ↗
Other Needle, Aspiration And Injection, Reusable devices
- Injection needle 50-353-23Spiggle & Theis Medizintechnik GmbH · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 recall0 reports
- Injection needle 50-345-23Spiggle & Theis Medizintechnik GmbH · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 recall0 reports
- ASPIRATION NEEDLE NA-1C-1Olympus Medical Systems Corp. · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 death5 reports
- Breast Localization Needles 253050Argon Medical Devices, Inc. · Needle, Aspiration And Injection, Reusable2 reports
- Breast Localization Needles 252100Argon Medical Devices, Inc. · Needle, Aspiration And Injection, Reusable1 report
- Breast Localization Needles 253125Argon Medical Devices, Inc. · Needle, Aspiration And Injection, Reusable1 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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