Breast Localization Needles 252100Recalls & reported problems
Argon Medical Devices, Inc. · Hawkins™ II FlexStrand™ BLN 20ga x 10cm · Class 1 · Implant
Data updated Oct 16, 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 00886333003822), received between Jan 17, 2022 and Jan 17, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Remove1
- Mechanical Jam1
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.
InjuryJan 17, 2022Difficult to Remove; Mechanical Jam
WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE
Patient problems: Insufficient Information
MAUDE report 13267124 ↗
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 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 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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