Arterial Needle 195311Recalls & reported problems
Argon Medical Devices, Inc. · AMC/3 Arterial Needle – 21ga x 1” (2.5cm) · Class 1
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 00886333208371), received between Jul 12, 2023 and Aug 23, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2023Material Fragmentation; Material Fragmentation
A NITREX GUIDEWIRE WAS BEING USED DURING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDIATRIC CARDIAC CATHETERIZATION. IT WAS USED IN 21G ARTERIAL NEEDLE. THE TIP OF THE NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY. IMMEDIATELY CONTACTED SURGEON AND PEDIATRIC SURGERY DOCTOR. IT WAS DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES.
Patient problems: Foreign Body In Patient
MAUDE report 17603463 ↗MalfunctionJul 12, 2023Material Fragmentation; Material Fragmentation
TIP OF NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY WHILE ATTEMPTING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH. IMMEDIATELY CONTACTED SURGEON, AND THEN PEDS SURGERY DOCTOR. DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES. DOCTOR NOTIFIED PATIENT FAMILY AT COMPLETION OF CASE. SPECIFIC ITEM: EV3 NITREX .018" X 80 CM GUIDEWIRE. REF#: (B)(4), LOT#: 6675783. USED IN CONJUNCTION WITH ARGON MEDICAL DEVICES AMC/3 ARTERIAL NEEDLE 21GA X 1" REF#: (B)(4). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH.
Patient problems: Foreign Body In Patient
MAUDE report 17305462 ↗
Other Guide, Needle, Surgical devices
- GHIATAS® 47920Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL20 reports
- DuaLok™ LW0107Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL11 reports
- GHIATAS® 47720Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- PERL Localization Device R2020Focal Therapeutics, Inc. · Guide, Needle, Surgical7 reports
- GHIATAS® 477201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- GHIATAS® 475201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL6 reports
- GHIATAS® 479201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0077Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
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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