BD Intraosseous Vascular Access System D015451NKRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741163609), received between Mar 2, 2021 and Sep 15, 2026 — classified as 1 death, 17 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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.

Recalls naming this device

1. 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 ↗

2. 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

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SOME ISSUE WITH SOME IO NEEDLES. WHEN DRILLING THE IO NEEDLES IN THE HUMERAL HEAD, THE NEEDLES ARE POPPING OUT (DISLODGING). NO FURTHER DETAILS AVAILABLE OR PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Insufficient Information; Unintended Loss of Vascular Access

  MAUDE report 24239977 ↗
• InjuryFeb 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SOME ISSUE WITH SOME IO NEEDLES. WHEN DRILLING THE IO NEEDLES IN THE HUMERAL HEAD, THE NEEDLES ARE POPPING OUT (DISLODGING). NO FURTHER DETAILS AVAILABLE OR PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Insufficient Information

  MAUDE report 24239975 ↗
• MalfunctionDec 4, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED NEEDLES JAMMING IN SHEATHS AND PULLING OUT OF PLACEMENT IN TRAINING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720000 ↗
• InjuryDec 4, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED NEEDLES JAMMING IN SHEATHS AND PULLING OUT OF PLACEMENT IN TRAINING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719989 ↗
• InjuryJul 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, IO FAILURE DURING CPR 45MM USED AND THE STYLET WOULD NOT DISENGAGE. NO INJURY/DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546538 ↗
• InjuryJul 14, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED; THE NEEDLE WOULD NOT DISCONNECT FROM THE HUB. THERE WERE NO SCARS/SIGNS OF HARDWARE. LOCATION SITE WAS DISTAL FEMUR, SIZE 45MM. NO INJURY DUE TO FAILURE. BUT IT WAS DURING A CPR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501556 ↗
• InjuryJul 1, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, EXPERIENCED ONGOING ISSUES WITH THE STYLET NOT REMOVING FREELY FROM THE IO NEEDLE. CUSTOMER REPORTS 4 EVENTS IN WHICH THEY WERE NOT ABLE TO RETRACT THE NEEDLE FROM THE IO HUB, WHICH IS AN ISSUE THEY HAVE REPLICATED IN THEIR TRAINING OFFICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 22371654 ↗
• InjuryJun 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THEY HAD A NEEDLE MALFUNCTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185075 ↗
• InjuryJun 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE NOT PULLING OUT EASILY/SMOOTHLY AND IT HAS TAKEN MULTIPLE ATTEMPTS AND PEOPLE TO GET THE NEEDLE OUT OF THE HUB AFTER IT HAS BEEN PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146505 ↗
• InjuryMay 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CUSTOMER THAT THEY HAVE EXPERIENCED MULTIPLE ISSUES INVOLVING DIFFICULTY REMOVING THE STYLET FROM THE IO NEEDLE. THE EXACT QUANTITY OF NEEDLES EXPERIENCING THE REPORTED ISSUE WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078789 ↗
• InjuryMay 1, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED DURING AN ATTEMPTED INSERTION, THE 45MM BDIO NEEDLE BENT BEFORE IT PENETRATED THE PATIENT'S BONE. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941402 ↗
• InjuryMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY CUSTOMER THAT BENT IO NEEDLES. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721847 ↗
• InjuryMar 3, 2025Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED THAT IO PROVIDER FELT LIKE THEY WERE IN THE BONE BUT IT WOULDN'T FLUSH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511301 ↗
• InjuryMar 3, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT ENTIRE NEEDLE CAME OUT OF BONE WHEN THEY WERE TO REMOVE THE NEEDLE. THEY¿RE SAYING THAT THEY PULLED STRAIGHT OUT BUT I¿M NOT SURE IF THEY TWISTED BEFORE THEY WENT TO PULL IT STRAIGHT OUT. THEY ALSO DISCONNECTED THE NEEDLE FROM THE DRIVER THEN PULLED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511299 ↗
• InjuryJan 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, DURING THE FIRST ATTEMPT, YELLOW NEEDLE, THE DRILL WASN'T GIVING ENOUGH POWER TO FULLY SEAT. HAD TO ATTEMPT 3 TIMES. AFTER IO SEATED, TRIED PULLING OUT THE NEEDLE PART PER THE INSTRUCTIONAL VIDEO. WASN'T COMING OUT. THEN TRIED TWISTING, NO LUCK. THEN TRIED TO TWIST AND PULL. STILL NO LUCK. WENT TO ATTEMPT SECOND DRILL ON OPPOSITE LEG WITH A DIFFERENT SIZE NEEDLE. WRONG SIZE WAS OPENED, THEN HANDED A THIRD IO NEEDLE, THE BLUE ONE. ABOUT TO ATTEMPT THE SECOND DRILL, AND THE INITIAL YELLOW NEEDLE FINALLY CAME OUT TO SECURE TUBING AND STABILIZER. PATIENT IMPACT: THERE WAS A DELAY IN RETRACTING THE INITIAL YELLOW IO NEEDLE. IT WASN'T COMING OUT TO ATTACH TUBING AND STABILIZER. HOWEVER, BEFORE SECOND DRILL ATTEMPT, USING THE BLUE IO NEEDLE, WE HAD SUCCESSFULLY RETRACTED THE INITIAL YELLOW E NEEDLE AND ATTACHED TUBING AND STABILIZER. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277444 ↗
• InjuryJan 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, IO NEEDLE BENDING WHEN BEING INSERTED. PATIENT WAS IN CARDIAC ARREST, WHEN THE IO COULD NOT BE PLACED. PATIENT DID NOT SURVIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21219006 ↗
• InjuryOct 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2022, WE RAN A CARDIAC ARREST. LOCATION FOR TIBIAL WAS ACCESSED AND WHEN BLUE NEEDLE WAS PLACED ON TIBIAL, ONCE TRIGGER WAS DEPRESSED, THE NEEDLE WAS JERKED VIOLENTLY IN USERS HAND AND BENT AT A FORTY-FIVE DEGREE ANGLE AT THE PLASTIC HUB WHERE THE SHAFT OF THE NEEDLE CONNECTS. IV ACCESS WAS ESTABLISHED ELSEWHERE AND SECURED WITH BD VENIGUARD. DURING ROUTINE FOLLOW UP, THE CLINICIAN REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577884 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER "ON 6/19 THE BDIO DURING A FULL ARREST CALL, THE BD IO GUN WAS UTILIZED WITH THE 45 MM IO NEEDLE. PARAMEDIC PROPERLY INSERTED THE NEEDLE IN THE CORRECT ANATOMICAL LOCATION (TIBIAL TUBEROSITY) AND USED THE EQUIPMENT 100% AS DIRECTED BY THE MANUFACTURER. THE IO NEEDLE FAILED TO RELEASE AND "BREAK AWAY" AS EXPECTED FROM THE MANUFACTURERS DESIGN. AFTER EXHAUSTING ALL MEANS TO TRY AND REMEDY THE PROBLEM (RE ATTACHING THE DRILL AND REPEATEDLY TORQUEING AS WELL AS MANUALLY TRYING BY HAND) IT WAS DETERMINED THAT THE NEEDLE NEEDED TO BE ABANDON AND A SECONDARY MEANS OF ACCESS BE GAINED. AT NO POINT DURING TRANSPORT WAS THE CREW ABLE TO FIX THE ISSUE WITH THE IO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977956 ↗
• MalfunctionMay 27, 2022Restricted Flow rate; Failure to Infuse; Restricted Flow rate; Failure to Infuse

  IT WAS REPORTED BY SALES REP "I EXPERIENCED RESTRICTED FLOW FROM THE T CONNECTOR ON THE BD IO EXTENSION WHEN ATTEMPTING TO FLUSH WITH 10 CC BD PREFILLED SYRINGES." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522466 ↗
• MalfunctionMay 7, 2022Activation Problem; Activation Problem

  IT WAS REPORTED BY SALES REP, "I DID A DEMO TODAY WITH PRODUCT AND THE SAFETY MECHANISM DID NOT ENGAGE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317080 ↗
• MalfunctionMay 6, 2022Defective Component; Defective Component

  IT WAS REPORTED "THE LUER NUT ON THE EXTENSION SET IS VERY "STICKY" AND TOUGH TO ADJUST AND ATTACH TO THE NEEDLE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307596 ↗