Breast Localization Needles 253050Recalls & reported problems
Argon Medical Devices, Inc. · Hawkins™ III FlexStrand™ BLN 20ga x 5cm · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333003860), received between Jun 9, 2022 and Jan 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Break1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Insufficient Information2
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size; Activation Problem
THE WIRE IS MOVING BACK AFTER BEING PLACED FOR BREAST NEEDLE LOC, THE WIRE DOESN'T APPEAR TO BE OPENING UP AT THE END GIVING IT THAT "V" WHICH HOLDS IT IN PLACE.
Patient problems: Insufficient Information; Needle Stick/Puncture
MAUDE report 16134004 ↗MalfunctionJun 9, 2022Break
WE RECEIVED ON JUNE 1ST LATE AFTERNOON THE FOLLOWING COMPLAINT FROM RABIN (BEILINSON) MEDICAL CENTER, AS OUTLINED BELOW THE HOSPITAL QUERIES IF THIS IS A KNOWN ISSUE, IF HAPPENED BEFORE AND IF REPORTED. PRODUCT DETAILS: ARGON BREAST LOCALIZATION NEEDLE BATCH 11401333 CAT NO 253050. COMPLAINT: ON 24 MAY 2022, A MARKING PRESS NEEDLE WAS INSERTED. DURING A SURGERY THAT DAY, IT BROKE. NO INFORMATION ABOUT PATIENT PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14644001 ↗
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 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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