Bone Marrow Aspiration Needle DBMNI1601Recalls & reported problems

Argon Medical Devices, Inc. · Bone Marrow Aspiration Needle 16ga x 2.688in Max · Class 2

Data updated Oct 18, 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 00886333001446), received between May 31, 2022 and May 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Device problems

Material Twisted/Bent1
Therapeutic or Diagnostic Output Failure1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 31, 2022Material Twisted/Bent; Therapeutic or Diagnostic Output Failure
BONE MARROW NEEDLE CANT HANDLE PRESSURE NECESSARY TO PENETRATE BONE, KINKS AND BENDS SLIPS AWAY FROM PENETRATION SITE DOES NOT CUT SAMPLE PROPERTY AND SHATTERS THE BONE SAME AS (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14549187 ↗

Device details

UDI-DI	`00886333001446`
Brand	Bone Marrow Aspiration Needle
Model	DBMNI1601
Company	Argon Medical Devices, Inc.
Product code	KNW · Instrument, Biopsy
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 11, 2026

Device type (GMDN): Bone marrow biopsy needle, single-use

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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