BD Intraosseous Vascular Access System D015251NKRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00801741163678), received between Jan 7, 2021 and May 11, 2026 — classified as 3 deaths, 9 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (21 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 47 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 2, 2026Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE IS TWISTED INSIDE OF THE SHAFT AND WILL NOT COME APART, EXCEPT WHEN USING PLIERS TO FORCE THEM APART. I HAD THEM DESCRIBE TO ME THE TECHNIQUE USED FOR INSERTION, AND THEY DID STATE THEY PULLED STRAIGHT UP. NO HARM WAS DONE OTHER THAN THE FAILED NEEDLE UPON INSERTION AND UNABLE TO SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765997 ↗
• MalfunctionMar 19, 2026Difficult to Remove

  IT WAS REPORTED THAT ADMIN STAFF OPENED TWO NEEDLES AT THE MAIN STATION RESULTING IN FAILURES. I HAD THEM DESCRIBE TO ME THE TECHNIQUE USED FOR INSERTION, AND THEY DID STATE THEY PULLED STRAIGHT UP ON ALL. THE NEEDLES ARE TWISTED INSIDE OF THE SHAFT AND WILL NOT COME APART, EXCEPT WHEN USING PLIERS TO FORCE THEM APART. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639600 ↗
• MalfunctionMar 19, 2026Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLES ARE TWISTED INSIDE OF THE SHAFT AND WILL NOT COME APART, EXCEPT WHEN USING PLIERS TO FORCE THEM APART. I HAD THEM DESCRIBE TO ME THE TECHNIQUE USED FOR INSERTION, AND THEY DID STATE THEY PULLED STRAIGHT UP ON ALL. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639110 ↗
• InjuryFeb 3, 2026Material Twisted/Bent

  IT WAS REPORTED I WAS DISPATCHED TO A CARDIAC ARREST. DURING THIS ARREST I PROCEEDED TO USE X2 IO NEEDLES THAT BOTH WERE DEFECTIVE. UPON PLACING THE FIRST IO NEEDLE I WENT TO DRILL AND THE NEEDLE BENT INTO ABOUT A 90 DEGREE ANGLE. IT WAS A HIGH CHAOS CALL SO I THOUGHT MAYBE IT WAS OPERATOR ERROR. I THEN PROCEEDED TO DO A SECOND IO AND HAD THE EXACT SAME THING HAPPEN. LUCKILY THE RESPONDERS ON SCENE HAD AN EXTRA IO AVAILABLE AND THEY WERE ABLE TO GET IT. I DID ASSESS THE PATIENTS LEG THINKING MAYBE A PROSTHETIC OR SOMETHING BUT DID NOT SEE ANY SCARS OR TRAUMA. NO IMPACT TO THE PATIENT PER THE CREW. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251875 ↗
• MalfunctionFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN DRILLING THE IO NEEDLE IN THE HUMERAL HEAD, THE NEEDLE ARE POPPING OUT (DISLODGING). PATIENT WAS IN CARDIAC ARREST FOR 5 MINUTES. NO DELAY IN MEDICATION, ALL MEDICATIONS WAS DELIVERED PRIOR TO EVENT (EPI, AMIO, SODIUM BICARB, CALCIUM CHLORIDE, NORMAL SALINE). ACCESS SITE WAS LEFT HUMORAL HEAD. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245257 ↗
• InjuryJan 29, 2026Difficult to Remove

  IT WAS REPORTED THAT STYLET SEPARATION FAILURE INVOLVING THE BD INTRAOSSEOUS (BD IO) SYSTEM USED BY OUR FIRE RESCUE MEMBERS. DURING A RECENT PATIENT ENCOUNTER, OUR CREW EXPERIENCED A SITUATION IN WHICH MULTIPLE STYLETS WOULD NOT DISENGAGE FROM THE NEEDLE HUB AFTER SUCCESSFUL INSERTION, RENDERING THE IO NONFUNCTIONAL AND REQUIRING IMMEDIATE ABANDONMENT OF THE SITE. STYLET REMAINED FIRMLY FIXED IN THE HUB DESPITE PROPER TECHNIQUE, STABILIZATION, AND CONTROLLED TRACTION. THE NEEDLE ASSEMBLY APPEARED FULLY SEATED ON THE DRIVER, BUT THE STYLET COULD NOT BE REMOVED (OTHER ATTEMPTS WERE MADE TO REMOVE THE NEEDLE FROM THE HUB). A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Unintended Loss of Vascular Access

  MAUDE report 24211882 ↗
• DeathJan 23, 2026Difficult to Remove

  ADDITIONAL INFORMATION PROVIDED 20-JAN-2026: UNFORTUNATELY, THE INABILITY TO REMOVE THE STYLET FROM THE CATHETER DELAYED ADMINISTRATION OF CRITICAL RESUSCITATIVE CARDIAC ARREST MEDICATIONS. 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 WAS PRONOUNCED DECEASED AT THE EMERGENCY DEPARTMENT AFTER RESUSCITATION ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Loss of Vascular Access

  MAUDE report 24164322 ↗
• MalfunctionJan 20, 2026Product Quality Problem; Difficult to Remove

  ADDITIONAL INFORMATION: TWO DEVICES WERE RETURNED FOR INVESTIGATION. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122227 ↗
• DeathJan 20, 2026Product Quality Problem; Difficult to Remove

  ADDITIONAL INFORMATION: THE ISSUE WITH THE IO NEEDLES DELAYED MEDICATION ADMINISTRATION. IV ACCESS WAS OBTAINED IN THE EXTERNAL JUGULAR. RESUSCITATION MEASURES WERE TAKEN. HOWEVER, THE PATIENT WAS PRONOUNCED DECEASED IN THE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122223 ↗
• MalfunctionNov 21, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES JAMMED IN THE SHEATH AND PULLED OUT OF PLACEMENT DURING USE. IT WAS REPORTED THIS OCCURRED DURING TRAINING WITH NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23616958 ↗
• InjuryNov 18, 2025Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES JAMMED IN THE SHEATH AND PULLED OUT OF PLACEMENT DURING USE. IT WAS REPORTED THIS OCCURRED DURING AN EMERGENCY MEDICAL SITUATION, DETAILS NOT PROVIDED. AN APPARENT DESIGN FLAW CAUSING THE NEEDLE TO JAM IN THE SHEATH AND NOT PULL OUT EFFECTIVELY. NO FURTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Insufficient Information

  MAUDE report 23585905 ↗
• InjuryNov 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE JAMMED IN THE SHEATH AND PULLED OUT OF PLACEMENT DURING USE. IT WAS REPORTED THIS OCCURRED DURING A PEDIATRIC ARREST. AN APPARENT DESIGN FLAW CAUSING THE NEEDLE TO JAM IN THE SHEATH AND NOT PULL OUT EFFECTIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585510 ↗
• InjuryAug 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED FIRE FIGHTER PARAMEDIC RESPONDED TO A CARDIAC ARREST PATIENT AND WHEN HE ATTEMPTED TO REMOVE THE STYLET FROM THE BDIO NEEDLE, THE STYLET BECAME STUCK. I ME WITH THE PARAMEDIC YESTERDAY, (B)(6) WHEN THE EMS CALL OCCURRED AND HE WAS NOT 100% SURE IF HE TWISTED THE BD IO TO REMOVE THE STYLET OR IF HE REMOVED IT BY PULLING STRAIGHT BACK. HE THEN STARTED AN IC ON THE PATIENT THAT HAD ROSC AND WAS TRANSPORTED BY THE LOCAL 911 PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839293 ↗
• MalfunctionJul 30, 2025Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  ADDITIONAL INFORMATION RECEIVED ON 8/18/2025: THE TRAUMA PATIENT WITH GUN SHOT WOUND (GSW), WAS A SITUATION WITH THE DRILL SEPARATING FROM THE HUB OR STYLET AND LEAVING THE NEEDLE CONNECTED TO THE OBTURATOR. PARAMEDIC TRIED BY HAND TO PULL UP THE NEEDLE AND IT WAS STUCK. THE PULL OUT A SECOND BD IO 25 MM NEEDLE AND IT INSERTED AND REMOVED WITHOUT A PROBLEM. THE DELAY WAS MINIMAL IN TERMS OF OUTCOME. PATIENTS WAS IN EXTREMIS AND WOULD HAVE BAD OUTCOME, AS NOT BEING A FACTOR IN THE OVERALL CONDITION. CAUSE OF DEATH COULD NOT BE PROVIDED FOR PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672280 ↗
• MalfunctionJul 30, 2025Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  ADDITIONAL INFORMATION RECEIVED ON 8/18/2025: AFTER PROPER INSERTION OF THE BD IO 25 MM NEEDLE INTO THE HUMERUS HEAD, THE STYLET HUB REMAINED AS THE DRILL SEPARATED FROM THE HUB CONNECTION. THE PARAMEDIC TRIED TO PULL ON THE UPPER PORTION OF THE STYLET BY HAND, IT WOULD NOT PULL UP. THE AMBULANCE PARAMEDIC WAS ABLE TO ESTABLISH A SECOND IO WITH THE EZ-IO IN THE OTHER ARM. THE DELAY WAS MINIMAL IN TERMS OF OUTCOME. PATIENT WAS IN EXTREMIS AND WOULD HAVE BAD OUTCOMES, AS NOT BEING A FACTOR IN THE OVERALL CONDITION. CAUSE OF DEATH COULD NOT BE PROVIDED FOR PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672278 ↗
• MalfunctionJun 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, 25MM 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 22323044 ↗
• InjuryJun 19, 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 22293181 ↗
• InjuryMay 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE CUSTOMER EXPERIENCED MULTIPLE ISSUES INVOLVING DIFFICULTY REMOVING THE STYLET FROM THE IO NEEDLE. THE EXACT QUANTITY OF NEEDLES EXPERIENCING THE REPORTED ISSUE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079845 ↗
• DeathApr 17, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER, "DURING A CARDIAC ARREST LAST NIGHT, BENT NEEDLE THAT MADE IT IMPOSSIBLE TO PLACE AN IO DEVICE. PARAMEDIC WAS UNABLE TO PLACE A IO DURING A CARDIAC ARREST DUE TO NEEDLES ET BENDING DURING PLACEMENT.. PARAMEDIC DID PLACE AN IV, HOWEVER, PATIENT EXPIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860542 ↗
• MalfunctionSep 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED STYLET IS STUCK, DOES NOT ALLOW FOR REMOVAL. THE GROOVES OF THE NEEDLE HUB AND DRIVE ADAPTER HUB BECOMING MISALIGNED, LEADING TO THE STYLET UNABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371381 ↗
• MalfunctionJul 28, 2022Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE IO WENT IN AS USUAL, BUT WHEN THEY WENT TO FLUSH IT THE PORT AT THE 90-DEGREE ELBOW BLEW OUT AND SPRAY THE PARAMEDIC IN THE FACE. PER MY INVESTIGATION THE PORT AT THE 90-DEGREE ELBOW WAS NOT TOUCHED WITH A SYRINGE PRIOR TO THE FAILURE AND DID NOT LOOK OUT OF THE ORDINARY WHEN THE PARAMEDIC ATTACHED IT TO THE IO IN THE EXTREMITY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121945 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6) 2022 CREW RESPONDED TO A RESPIRATORY CALL WHICH ENDED UP BECOMING A FULL ARREST. PARAMEDIC USED THE BLUE 25MM IO NEEDLE ON THE LEFT TIBIAL TUBEROSITY. ONCE INSERTED, MEDIC HAD ATTEMPTED TO REMOVE THE NEEDLE FROM THE CATHETER AND THE ENTIRE NEEDLE CAME OUT ALONG WITH THE CATHETER. A SECOND ATTEMPT WAS ISSUED ON THE RIGHT TIBIAL TUBEROSITY BUT WITH MORE PRESSURE APPLIED. THE NEEDLE THEN CAME OUT WITH NO ISSUE AND THE IO WAS SUCCESSFUL. PATIENT WAS THEN TREATED PER TREATMENT GUIDELINES AND NO OTHER ISSUES WERE NOTED ON THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978126 ↗
• MalfunctionJun 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IO NEEDLE FAILURE RECENTLY. NEEDLE BENT DURING THE INSERTION. PARAMEDIC WAS ON 793 ON FRIDAY, (B)(6) 2022. HE WENT TO INSERT A 25 MM GAUGE IO (BLUE) INTO THE PROXIMAL TIBIA ON A PT IN CARDIAC ARREST. PARAMEDIC REPORTED WITH MINIMAL PRESSURE APPLIED DURING THE PROCEDURE, THE IO NEEDLE BENT, RESULTING IN ABORTING FURTHER ATTEMPT AT INSERTION OF THAT PARTICULAR IO NEEDLE. "

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734828 ↗