BD Intraosseous Vascular Access System D015351NKRecalls & reported problems

Bard Access Systems, Inc. · BD Intraosseous Needle Set Kit · Class 2

All models of BD Intraosseous Vascular Access System (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741163593), received between Jun 27, 2025 and Feb 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jul 30, 2026Class IOpen, Classified
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy
Z-2872-2026 · Root cause: Component change control · Recall details · FDA record ↗
Jun 20, 2022Class IOpen, Classified
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
Z-1397-2022 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Device problems

Difficult to Remove1
Material Deformation1
Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 23, 2026Material Deformation; Material Twisted/Bent
IT WAS REPORTED AN IO NEEDLE BENT DURING A RECENT TRAINING EVENT IN A CADAVER LAB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423211 ↗
MalfunctionJun 27, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT 35MM NEEDLE NOT SEPARATING AFTER INSERTION. THIS WAS A TYPICAL INSERTION. NOTHING WAS ABNORMAL DURING THE INSERTION PROCESS. THE DRILL WORKED PERFECTLY, AND INSERTION WAS ON THE PATIENT'S TIBIA. THERE WAS NO PATIENT HARM. THE NEEDLES WERE USED IN A CADAVER LAB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22347822 ↗

Device details

UDI-DI	`00801741163593`
Brand	BD Intraosseous Vascular Access System
Model	D015351NK
Company	Bard Access Systems, Inc.
Product code	FMI · Needle, hypodermic, single lumen
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	Mar 25, 2021

Device type (GMDN): Intraosseous infusion kit

A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. 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 · each recall links to the FDA recall notice
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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