BD Intraosseous Vascular Access System D001001Recalls & reported problems
Bard Access Systems, Inc. · BD Intraosseous Powered Driver · Class 2
All models of BD Intraosseous Vascular Access System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the BD Intraosseous Powered Driver, a hand-held drill used to place intraosseous needles into bone when IV access is hard to obtain. The 51 reports mostly describe the drill not powering up, cutting out mid-procedure, or losing power during insertion, along with needles not staying attached;4 reports involve injuries and no deaths. One open recall from June 2022 covers needle kits where the stylet could stick, pull the whole needle out, or fail to lock in place.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741163579), received between Nov 9, 2020 and Sep 23, 2026 — classified as 5 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (25 reports).
1 FDA recall record name this device's identifier, 1 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
- 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
- Failure to Power Up25
- Mechanical Problem13
- No Apparent Adverse Event11
- Unexpected Shutdown7
- Data Problem5
- Loose or Intermittent Connection3
- Failure to Charge2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 55 reports, 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 ↗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 ↗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 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 ↗MalfunctionApr 3, 2026Mechanical Problem
IT WAS REPORTED THE IO DRIVER AND NEEDLE COMBINATION DID NOT PERFORM AS EXPECTED. SPECIFICALLY, WE HAVE HAD MULTIPLE REPORTS OF THE DRIVER NOT APPEARING TO HAVE ENOUGH POWER TO ADEQUATELY PENETRATE THE BONE. NO FURTHER INFORMATION WAS PROVIDED. AN EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777702 ↗MalfunctionMar 2, 2026Unexpected Shutdown
IT WAS REPORTED UNIT CUTS OUT DURING PROCEDURES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490044 ↗MalfunctionFeb 24, 2026Mechanical Problem; No Apparent Adverse Event
IT WAS REPORTED NEEDLES NOT STAYING MAGNETIZED TO DRILL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428711 ↗MalfunctionFeb 20, 2026Failure to Charge; Mechanical Problem
IT WAS REPORTED THE DRILL SHOWS FULLY CHARGED BUT HAS INTERMITTENT DRILLING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403083 ↗MalfunctionFeb 18, 2026No Apparent Adverse Event; Unexpected Shutdown
IT WAS REPORTED SUSPECTED LOSS OF POWER DURING IO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24383097 ↗MalfunctionFeb 17, 2026Mechanical Problem; Product Quality Problem
IT WAS REPORTED THAT INTERNAL COMPONENTS SHAKE AND MOTOR FEELS WEAKER THAN NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364386 ↗MalfunctionDec 30, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE DRILL SHOWS FULLY CHARGED BUT HAS INTERMITTENT DRILLING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922062 ↗MalfunctionDec 22, 2025Data Problem; Data Problem
IT WAS REPORTED THAT WHEN USING THE DRILL IT DOES NOT SHOW THE CHARGE EVEN IF THEY PLUG IT IN. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864852 ↗MalfunctionNov 19, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A CARDIAC ARREST ON (B)(6) THERE WAS A PROBLEM WITH THE IO DEVICE. IT HAS BEEN PLACED IN THE PATIENT, BUT THE NEEDLE WAS JAMMED, AND WE WERE UNABLE TO REMOVE THE NEEDLE FROM THE CATHETER. THIS RESULTED IN OPENING TWO ADDITIONAL NEEDLES; ONE WAS USED TO ASSESS HOW THE TWO ELEMENTS CONNECT BUT WAS JUDGED TO BE TOO LONG TO USE ON THE PATIENT'S LEG. ANOTHER NEEDLE WAS OPENED AND PLACED ON THE PATIENT, AND IT DID WORK AND WE WERE ABLE TO OVERCOME THE PROBLEM, BUT IT CERTAINLY CREATED ANXIETY ON SCENE AND RESULTED IN A LESS EFFICIENT RUN THAN IS DESIRABLE. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595614 ↗InjuryNov 11, 2025No Apparent Adverse Event; Unexpected Shutdown; No Apparent Adverse Event; Unexpected Shutdown
IT WAS REPORTED THAT THE DRILL TEMPORARILY STOPPED WORKING MID PROCEDURE AND ALL 4 LIGHTS FLASHED GREEN. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526481 ↗MalfunctionNov 4, 2025Failure to Power Up; No Apparent Adverse Event; Failure to Power Up; No Apparent Adverse Event
IT WAS REPORTED THAT DURING NORMAL CHECK OFF THE UNIT SHOWED TWO GREEN LIGHTS BUT WHEN SQUEEZING THE TRIGGER FOR THE SECOND TEST IT FAILED AND WENT DEAD. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468316 ↗MalfunctionOct 29, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE TRIGGER FOR THE DRILL IS NOT ENGAGING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418544 ↗MalfunctionSep 16, 2025Data Problem; Data Problem
IT WAS REPORTED UNIT ISN¿T HOLDING A CHARGE DESPITE SHOWING 3 GREEN LIGHTS WHEN PLUGGED IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063764 ↗MalfunctionAug 12, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE DRILL DISPLAYS ALL FOUR LIGHTS WHEN PLUGGED INTO CHARGER BUT NOTHING HAPPENS WHEN THEY USE THE DRILL. VERIFIED THEY HAVE TRIED USING THE DRILL WITH IT PLUGGED IN AND WITH IT DISCONNECTED FROM THE CHARGER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790526 ↗MalfunctionAug 7, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE DRILL EITHER WON'T CHARGE OR IF IT DOES CHARGE, IT WILL SHOW 3 LIGHTS AND THEN AFTER LETTING GO OF THE TRIGGER, IT WILL NOT WORK AGAIN. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738590 ↗MalfunctionJul 16, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED DRIVER SHOWS A FULL CHARGE, BUT WHEN THE TRIGGER IS PULLED, THE DRIVER WILL EITHER PAUSE OR NOT WORK AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523212 ↗MalfunctionJun 20, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DRILL IS NOT HOLDING A CHARGE. ADDITIONAL INFORMATION RECEIVED ON (B)(6). "I WAS SHOWING NO CHARGE OR REF LIGHTS SHOWING UP, I PLACED IT ON THE CHARGER AND AS I CONNECTED IT THE LIGHT SHOWED UP A FULL 4 DOTS AND TURNED ON, IT IS RUNNING SLOW AND JERKS LIKE IT COULDN'T SPIN AND STOPS." NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297390 ↗MalfunctionJun 17, 2025Failure to Power Up; No Apparent Adverse Event; Failure to Power Up; No Apparent Adverse Event
IT WAS REPORTED DRILL HAVING ISSUES POWERING ON WHEN FULLY CHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235665 ↗
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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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