BD Intraosseous Vascular Access SystemRecalls & reported problems across all models

We found 11 models of BD Intraosseous Vascular Access System by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2020 and Sep 23, 2026 — classified as 6 deaths, 32 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (39 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Intraosseous Vascular Access System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 30, 2026Open, 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 · names 5 of these models · Recall details · FDA record ↗

2. Jun 20, 2022Open, 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 · names 11 of these models · Recall details · FDA record ↗

Most reported BD Intraosseous Vascular Access System problems

BD Intraosseous Vascular Access System models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Intraosseous Vascular Access System D015251NK

  Needle, hypodermic, single lumen
  2 recalls3 deaths47 reports
• BD Intraosseous Vascular Access System D015451NK

  Needle, hypodermic, single lumen
  2 recalls1 death35 reports
• BD Intraosseous Vascular Access System D015151NK

  Needle, hypodermic, single lumen
  2 recalls1 death9 reports
• BD Intraosseous Vascular Access System D001001

  Needle, hypodermic, single lumen
  1 recall55 reports
• BD Intraosseous Vascular Access System D015551NK

  Needle, hypodermic, single lumen
  2 recalls1 death3 reports
• BD Intraosseous Vascular Access System D015351NK

  Needle, hypodermic, single lumen
  2 recalls2 reports
• BD Intraosseous Vascular Access System D015151MK

  Needle, hypodermic, single lumen
  1 recall0 reports
• BD Intraosseous Vascular Access System D015251MK

  Needle, hypodermic, single lumen
  1 recall0 reports
• BD Intraosseous Vascular Access System D015351MK

  Needle, hypodermic, single lumen
  1 recall0 reports
• BD Intraosseous Vascular Access System D015451MK

  Needle, hypodermic, single lumen
  1 recall0 reports
• BD Intraosseous Vascular Access System D015551MK

  Needle, hypodermic, single lumen
  1 recall0 reports

Recent BD Intraosseous Vascular Access System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Unexpected Shutdown

  It was reported BD IO driver showed four green dots for a full charge but when we went to use it, it stopped halfway and then started blinking four red lights. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863382 ↗
• MalfunctionSep 22, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853501 ↗
• DeathSep 15, 2026Difficult to Remove

  It was reported by the customer that they had a failed IO attempt with a defective needle over the weekend. EMTs arrived on the scene of a 47 year old male in cardiac arrest. They started high-performance CPR, providing compressions, securing the airway, and attaching the patient to the AED. E207 EMTs arrived a few minutes later. This crew was tasked with obtaining IO access in the right humeral head. The Lieutenant removed the IO case from their red EMS bag and pulled out the drill and yellow needle. He then put the needle onto the drill and located the access point for the patient's right humeral head. He inserted the needle into the arm until he felt it touch the bone and then activated the drill, stopping once the IO had been set into place. He pulled the drill straight back and set it next to the patient and then attempted to attach the included tubing only to identify that the internal needle had not been removed from the drill site. He made several attempts to twist the needle to remove it and was unable to get the inner portion free. Three other medics also attempted to remedy the situation with no success. A second IO was placed in the tibia and they were able to use this

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775085 ↗
• InjurySep 10, 2026Material Twisted/Bent

  It was reported by customer that attempted to insert IO needle into patient, IO needle bent upon insertion during code situation.Additional information received on 8/27/2026:The patient immediately received another IO to administer medications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713082 ↗
• MalfunctionAug 25, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434972 ↗
• MalfunctionAug 11, 2026Failure to Power Up

  It was reported that the drill is not responding when trigger is pressed. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216846 ↗
• MalfunctionAug 11, 2026Mechanical Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209935 ↗
• InjuryAug 6, 2026Material Twisted/Bent

  Additional information received 30-Jul-2026: Patient did not have any other vascular access available during transport to the emergency department. Patient expired. Patient was in respiratory arrest when the first IO needle was attempted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161528 ↗
• InjuryMay 11, 2026Difficult to Remove

  IT WAS REPORTED STYLETS NOT BEING ABLE TO DISCONNECT ONCE PLACED IN THE BONE OF CARDIA ARREST PATIENTS. THEY DID GET ACCESS WITH A SECOND ONE, NO BAD OUTCOMES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144075 ↗
• MalfunctionMay 6, 2026Difficult to Remove

  IT WAS REPORTED THAT STYLET NOT BEING ABLE TO DISCONNECT ONCE PLACED IN THE BONE. ADDITIONAL INFORMATION RECEIVED: EVENT OCCURRED DURING A CARDIAC ARREST. THERE WERE NO BAD OUTCOME FOLLOWING THE USE OF THE IO NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107995 ↗
• MalfunctionApr 28, 2026Failure to Power Up

  IT WAS REPORTED THAT WHEN TRIGGER IS PULLED, IT DID NOT WORK. CUSTOMER SMACKED UNIT IT A FEW TIMES AND THEN IT WORKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019926 ↗
• 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 ↗
• MalfunctionApr 13, 2026Failure to Power Up

  IT WAS REPORTED AFTER CHARGING IT, THE DEVICE IS INOPERABLE WHEN HE SQUEEZES THE TRIGGER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865725 ↗
• InjuryApr 6, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION (B)(6). NEEDLE WOULDN¿T REMOVE FREELY OR WOULD PULL OUT THE ENTIRE NEEDLE:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791151 ↗

Other Bard Access Systems, Inc. products

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