BD Intraosseous Vascular Access System D015551NKRecalls & 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
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741163616), received between Mar 12, 2025 and Dec 8, 2025 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 reports).
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
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 Remove2
- Product Quality Problem2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Arrest1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove
IT WAS REPORTED BY CUSTOMER THAT THEY HAD SEVERAL OCCURRENCES OF NEEDLES JAMMING IN SHEATHS AND PULLING OUT OF PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742887 ↗MalfunctionDec 8, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove
IT WAS REPORTED BY CUSTOMER THAT THEY HAD SEVERAL OCCURRENCES OF NEEDLES JAMMING IN SHEATHS AND PULLING OUT OF PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742665 ↗DeathMar 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE 55MM NEEDLE IT BENT. THE PATIENT WAS A FULL CODE AND REQUIRED A SECONDARY SITE AT THE HUMORAL HEAD THAT WAS UTILIZED WITH SUCCESS. AFTER RESUSCITATION EFFORTS, PT WAS CONFIRMED DEAD ON SCENE FOLLOWING OUR MEDICAL DIRECTOR OFF LINES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Cardiac Arrest
MAUDE report 21586569 ↗
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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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