Breast Localization Needles 253125Recalls & reported problems
Argon Medical Devices, Inc. · Hawkins™ III FlexStrand™ BLN 20ga x 12.5cm · Class 1 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333003884), received between May 9, 2025 and May 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
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.
MalfunctionMay 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
"WHEN WE PARK THE ANGLER WIRE IN THE PATIENT & REMOVED THE NEEDLE IN THE PATIENT, THE WIRE WAS STUCK INSIDE THE NEEDLE AND CARRIED OUT WITH THE NEEDLE." MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 21995495 ↗
Other Needle, Aspiration And Injection, Reusable devices
- Injection needle 50-345-23Spiggle & Theis Medizintechnik GmbH · NEEDLE, ASPIRATION AND INJECTION, REUSABLE1 recall0 reports
- Injection needle 50-353-23Spiggle & 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 252125Argon Medical Devices, Inc. · Needle, Aspiration And Injection, Reusable2 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
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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