BD Intraosseous Vascular Access System D015151NKRecalls & 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
- 9
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741163586), received between Mar 11, 2022 and Apr 16, 2026 — classified as 1 death, 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (4 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 Remove4
- Defective Component3
- Product Quality Problem2
- Activation Problem1
- Failure to Infuse1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Unintended Loss of Vascular Access1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Product Quality Problem; Difficult to Remove
IT WAS REPORTED BY CUSTOMER THAT DIFFICULTY SEPARATING NEEDLE AND OBTURATOR. NO FURTHER DETAILS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903677 ↗MalfunctionApr 16, 2026Product Quality Problem; Difficult to Remove
IT WAS REPORTED BY THE CUSTOMER THAT DIFFICULTY SEPARATING NEEDLE AND OBTURATOR. NO FURTHER DETAILS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896215 ↗DeathFeb 5, 2026Difficult to Remove
IT WAS REPORTED BY THE CUSTOMER THAT IV ACCESS WAS ATTEMPTED WITH NO SUCCESS. IO ESTABLISHMENT WAS ATTEMPTED. NUMEROUS ATTEMPTS WERE MADE TO REMOVE THE STYLET FROM THE CATHETER ONCE ESTABLISHED IN THE PATIENT¿S PROXIMAL TIBIA WITH NO SUCCESS. THE PROVIDERS WERE UNABLE TO DISLODGE THE STYLET FROM THE CATHETER, CAUSING SIGNIFICANT DELAY AND THE INABILITY TO ADMINISTER APPROPRIATE MEDICATION(S.) THE SIGNIFICANT DELAY OF MEDICATION ADMINISTRATION HINDERED THE CARDIAC ARREST RESUSCITATION ATTEMPT. THE PATIENT FROM THE INCIDENT WAS PRONOUNCED DECEASED AT THE EMERGENCY DEPARTMENT AFTER RESUSCITATION ATTEMPT.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 24272431 ↗InjuryMar 17, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT PATIENT NEEDED A IO THEY WERE ABLE TO ESTABLISH ONE IN THE FEMUR WITH THE RED 15MM BUT HAD TROUBLE SEPARATING THE NEEDLE AFTER DRILLING. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621487 ↗MalfunctionAug 18, 2022Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER "INCIDENT OCCURRED ON NEWBORN BABY IN OPERATING ROOM AFTER MOTHER GAVE BIRTH VIA CAESAREAN SECTION. NEWBORN WAS TRANSFERRED TO A FACILITY." CUSTOMER SHARED THAT A 15MM IO NEEDLE WAS USED. NO OTHER INFORMATION WAS PROVIDED. ADVERSE IMPACT TO PATIENT IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15255396 ↗MalfunctionApr 29, 2022Defective Component; Defective Component
IT WAS REPORTED "IN 2 INSTANCES AFTER INSERTION INTO THE BONE, THE TROCAR COULD NOT BE REMOVED." THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251637 ↗MalfunctionApr 29, 2022Defective Component; Defective Component
IT WAS REPORTED "IN 2 INSTANCES AFTER INSERTION INTO THE BONE, THE TROCAR COULD NOT BE REMOVED." THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251631 ↗MalfunctionApr 29, 2022Defective Component; Defective Component
IT WAS REPORTED AFTER INSERTION INTO THE BONE, THE TROCAR COULD NOT BE REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251627 ↗MalfunctionMar 11, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED CANNOT INFUSE THROUGH THE T CONNECTOR PORT WHEN THE SYRINGE IF FULLY THREADED ON THE CONNECTOR. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13736061 ↗
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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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