ARROW IPN915667Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10816000013813), received between Feb 1, 2021 and Apr 11, 2023 — classified as 1 death, 79 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (42 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT "THE DEVICE DID NOT WORK DESPITE THE GREEN LIGHT ON THE BACK OF THE DEVICE". PER THE CUSTOMER, THIS DEVICE IS MORE THAN 10 YEARS OLD. ADDITIONAL INFORMATION STATES THAT THE PATIENT WAS DEHYDRATED AND NEEDED ADMINISTRATION OF FLUID. THE PATIENT HAD 1 PIV ESTABLISHED PRIOR TO THE EVENT. THE PATIENT WAS IN CARDIAC ARREST BEFORE A DECISION WAS MADE TO INSERT ANOTHER PIV. TWO ATTEMPTS TO INSERT A 2ND PIV WERE UNSUCCESSFUL. IT WAS THEN DECIDED, 10 MINUTES INTO CARDIAC ARREST, TO GAIN ACCESS VIA I.O. THE EZ-IO WAS ATTEMPTED TO BE INSERTED IN THE PROXIMAL TIBIA, HOWEVER "THE DRIVER STOPPED SPINNING WHEN THE I.O. NEEDLE HIT THE BONE". I.O. ACCESS WAS NOT SUCCESSFULLY ACHIEVED. THE OPERATOR OF THE DEVICE HAD INSERTED AN I.O. PREVIOUSLY AND ATTEMPTED TO MANUALLY INSERT IT ONCE THE DRIVER STOPPED. A BACKUP DRIVER WAS AVAILABLE BUT THE CUSTOMER STATED THAT IT WAS LOCATED TOO FAR AWAY. THE PATIENT EXPIRED.

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

  MAUDE report 16716153 ↗
• MalfunctionApr 4, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: PARAMEDIC TRYING TO INSERT THE EZ-IO NEEDLE AND ALTHOUGH IT WAS A GREEN LIGHT IT WOULD NOT WORK; THE IO WAS INSERTED MANUALLY.

  Patient problems: Insufficient Information

  MAUDE report 16678655 ↗
• MalfunctionApr 4, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: ALTHOUGH THE LED INDICATOR LIGHT IS GREEN, THE NEEDLE COULD NOT BE DRILLED INTO THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 16676520 ↗
• MalfunctionMar 30, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: DRIVER BATTERY STOPPED WORKING IN THE MIDDLE OF AN INSERTION; INSERTION COMPLETED BY MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649093 ↗
• MalfunctionMar 30, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: DURING A RESUSCITATION, THE DRIVER LOST POWER EVEN THOUGH THE LED WAS STILL GREEN. THE NEEDLE WAS SUCCESSFULLY INSERTED MANUALLY, PATIENT WAS NOT INJURED OR HARMED DUE TO THE DEFECT. PATIENT IS ALIVE; TRANSFERRED TO HOSPITAL IN ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648637 ↗
• MalfunctionMar 30, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: THE DRIVER HAD INSERTED HALFWAY THEN FAILED. THE SAME FAILURE OCCURRED WITH A SECOND ATTEMPT. INSERTION WAS ATTEMPTED IN THE PROXIMAL TIBIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644588 ↗
• MalfunctionMar 27, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: THE SAME DRIVER FAILED DURING 2 DIFFERENT RESUSCITATIONS ON 2 DIFFERENT PATIENTS: AFTER THE DRIVER FAILED INITIALLY FAILED ON ONE PATIENT, IT WAS TESTED ON AN ARTIFICIAL BONE AND WORKED PERFECTLY. THUS, IT WAS PUT BACK INTO USE, BUT THEN FAILED AGAIN ON ANOTHER PATIENT. IN BOTH CASES, A REPLACEMENT DRIVER WAS AVAILABLE AND IO ACCESS WAS ACHIEVED WITH THE REPLACEMENT DRIVER. THERE WAS NO DELAY IN TREATMENT. BOTH PATIENTS WERE NOT HARMED BY THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622475 ↗
• MalfunctionMar 27, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: THE SAME DRIVER FAILED DURING 2 DIFFERENT RESUSCITATIONS ON 2 DIFFERENT PATIENTS: AFTER THE DRIVER FAILED INITIALLY FAILED ON ONE PATIENT, IT WAS TESTED ON AN ARTIFICIAL BONE AND WORKED PERFECTLY. THUS, IT WAS PUT BACK INTO USE, BUT THEN FAILED AGAIN ON ANOTHER PATIENT. IN BOTH CASES, A REPLACEMENT DRIVER WAS AVAILABLE AND IO ACCESS WAS ACHIEVED WITH THE REPLACEMENT DRIVER. THERE WAS NO DELAY IN TREATMENT. BOTH PATIENTS WERE NOT HARMED BY THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622463 ↗
• MalfunctionMar 7, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: DURING CPR THE DRIVER HAD A POWER FAILURE WHILE ATTEMPTING TO INSERT THE IO IN THE LEFT TIBIA WITH A 45MM NEEDLE. THE DRILL SOUNDED CHARGED AND HAD A GREEN LIGHT 2 DAYS PRIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497411 ↗
• MalfunctionFeb 27, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: ALTHOUGH THE LED CONTROL LAMP LIGHTS UP GREEN, THE NEEDLE COULD NOT BE DRILLED INTO THE BONE. THE GREEN LED WENT OUT. STATUS RED FLASHING LED DID NOT APPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448496 ↗
• MalfunctionFeb 16, 2023Complete Loss of Power; Complete Loss of Power

  THIS CUSTOMER HAD USED THIS DRIVER MULTIPLE TIMES AND BENT THE NEEDLE ON THE FIRST TRY, AND THE SECOND TRY REALIZED THE DRIVER HAD BEEN FLASHING READ, AND ON THE 3RD TRY HAD A NEW DRIVER AND WAS ABLE TO PLACE AN IO ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385642 ↗
• MalfunctionFeb 13, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED EVENT: TWO IO ATTEMPTS WERE MADE BEFORE TRYING AN IV ATTEMPT. IO INSERTION WAS ACHIEVED ON THE THIRD ATTEMPT. THE PATIENT IS DECEASED. THE EVENT DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369228 ↗
• MalfunctionFeb 13, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED EVENT: THE DRIVER'S LED WAS STILL GLOWS GREEN BUT HAD A SIGNIFICANT DROP IN PERFORMANCE WHEN USED ON THE PATIENT, SO THE YELLOW NEEDLE COULD NOT BE INSERTED INTO THE PROXIMAL TIBIA. WHETHER THE PUNCTURE SITE WAS CORRECT IS UNKNOWN. ACCORDING TO THE CUSTOMER, THE DRIVER RAN NORMALLY AT FIRST, THEN IT BECAME HEAVIER AND FINALLY STOPPED. IT IS NOT KNOWN AND COULD NOT BE DETERMINED WHETHER THE PRESSURE WAS INCREASED. THE DRIVER WAS USED DURING A RESUSCITATION. THE IO NEEDLE WAS INSERTED MANUALLY WITH NO PATIENT INJURY. THE MALFUNCTION DID NOT CONTRIBUTE TO THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 16368985 ↗
• MalfunctionFeb 8, 2023Complete Loss of Power; Complete Loss of Power

  REPORTED EVENT: DURING RESUSCITATION, THE DRILL FAILED AND COULD NOT INSERT THE NEEDLE INTO THE BONE. THE LED LIGHT WAS GREEN. THE PATIENT IS DECEASED AND THE DEATH IS UNRELATED TO THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16327574 ↗
• MalfunctionJan 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTED EVENT: NEEDLES NOT CONNECTING TO DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265313 ↗
• MalfunctionDec 22, 2022Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: LOSS OF POWER DURING ATTEMPT TO DRILL THE NEEDLE INTO THE BONE. THIS OCCURRED DURING REANIMATION. THE LED WAS GREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039790 ↗
• MalfunctionDec 22, 2022Complete Loss of Power; Complete Loss of Power

  DRIVER STOPPED WORKING WHILE USING. THE PATIENT WAS IN FULL TRAUMA, UNRESPONSIVE AND INTUBATED AND GAINING IO ACCESS DID NOT CONTRIBUTE TO THE PATIENT'S STATUS. THE INSERTION SITE WAS THE PROXIMAL TIBIA WITH A LARGE AMOUNT OF PRESSURE BY AN EXPERIENCED OPERATOR. MANUAL PLACEMENT WAS NOT ATTEMPTED AS OTHER VASCULAR ACCESS WAS GAINED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034778 ↗
• MalfunctionNov 30, 2022Complete Loss of Power; Complete Loss of Power

  DRIVER LIGHT FLASHING GREEN, STOPPED WORKING DURING INSERTION. A BACK UP DRIVER WAS USED FOR INSERTION AND THE PATIENT WAS FINE WHEN TRANSPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890736 ↗
• MalfunctionNov 23, 2022Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: MEDICS TESTED DRIVER SERIAL NUMBER (B)(4) PRIOR TO SHIFT AND IT WORKED FINE. THEN SHOWED UP ON SCENE AND THE DRIVER HAD NO POWER TO INSERT IN THE TIBIA. AT THAT TIME THE MEDICS GRABBED A SECOND DRIVER (B)(4) FROM ANOTHER CREW AND BEGAN INSERTING ON THE PATIENT. DURING THE INSERTION THE DRIVER FAILED AND STOPPED WORKING ALL TOGETHER AND FAILED TO INSERT THE NEEDLE FULLY. AT THIS POINT MEDICS WERE ABLE TO COMPLETE INSERTION MANUALLY. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854146 ↗
• MalfunctionNov 23, 2022Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: MEDICS TESTED DRIVER SERIAL NUMBER (B)(4) PRIOR TO SHIFT AND IT WORKED FINE. THEN SHOWED UP ON SCENE AND THE DRIVER HAD NO POWER TO INSERT IN THE TIBIA. AT THAT TIME THE MEDICS GRABBED A SECOND DRIVER J27798 FROM ANOTHER CREW AND BEGAN INSERTING ON THE PATIENT. DURING THE INSERTION THE DRIVER FAILED AND STOPPED WORKING ALL TOGETHER AND FAILED TO INSERT THE NEEDLE FULLY. AT THIS POINT MEDICS WERE ABLE TO COMPLETE INSERTION MANUALLY. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854108 ↗
• MalfunctionNov 18, 2022Complete Loss of Power; Complete Loss of Power

  REPORTED ISSUE: MEDICS SHOWED UP ON SCENE AND TESTED THE DRIVER PRIOR TO INSERTION IN THE TIBIA. DURING INSERTION THE DRIVER STOPPED AND FAILED TO INSERT THE NEEDLE FULLY. MEDIC WERE NOT ABLE TO COMPLETE INSERTING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827634 ↗
• MalfunctionSep 27, 2022Complete Loss of Power; Complete Loss of Power

  WE HAVE AN EZ IO DRIVER MODEL 9065 , S/N (B)(6), THAT NO LONGER WORKS. THE CREW ATTEMPTED TO USE IT ON A CALL, WHEN THEY PRESSED THE TRIGGER, THE BATTERY INDICATOR BRIEFLY FLASHED RED , THE DRIVER BRIEFLY MOVED ROTATED THEN STOPPED. WE NOTICED THAT THE CASING NEAR THE TOP/SIDE SEEMS TO BE WARPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494365 ↗
• MalfunctionSep 23, 2022Complete Loss of Power; Complete Loss of Power

  EZ-IO POWER DRIVER FAILED TO OPERATE. THE LIGHT WOULD INITIALLY ILLUMINATE GREEN FOR LESS THAN A SECOND AND THEN THE DEVICE WOULD DIE OUT. THE DEVICE NO LONGER HAS ANY LIGHT TURN ON AND DOES NOT WORK. THERE WAS NEVER A RED LIGHT THAT ILLUMINATED ON THE DEVICE. ANOTHER DRIVER WAS OBTAINED. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470725 ↗
• MalfunctionSep 6, 2022Complete Loss of Power; Complete Loss of Power

  DRIVER BOGGED DOWN ON USE OF A PATIENT. THEY WERE UNSUCCESSFUL WITH PLACING MANUAL INSERTION AND THE USER WAS NOT SURE THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363019 ↗
• MalfunctionAug 23, 2022Complete Loss of Power; Complete Loss of Power

  ON (B)(6) 2022, EMS WAS CALLED FOR AN UNKNOWN PROBLEM, PERSON DOWN. UPON ARRIVAL THE PATIENT WAS IN CARDIAC ARREST. I RETRIEVED THE IO DRILL, FROM THE YELLOW CASE, IN THE BLUE JUMP BAG. I PREPPED THE FLUSH AND SELECTED THE BLUE IO NEEDLE AND DEEMED IT TO BE THE CORRECT SIZE. PER PERSONAL HABIT, EVERY TIME I USE THE IO, I WILL SQUEEZE THE TRIGGER BEFORE PLACING THE NEEDLE ON THE DRILL, TO CHECK THE BATTERY LIGHT. THE BATTERY LIGHT WAS SOLID GREEN, AND I PROCEEDED TO PLACE THE NEEDLE ON THE HUB AND BEGIN ACCESS. DURING OPERATION, THE DRILL BOGGED DOWN AND THE LIGHT BEGAN FLASHING RED AND STOPPED. THE IO WAS NOT SUCCESSFULLY IN PLACE AND THE TRIGGER WAS SQUEEZED AND HELD SO THE IO NEEDLE COULD BE TWISTED IN MANUALLY. THE MORNING CHECKS HAVE ALWAYS BEEN GREEN SINCE RECEIVING THE UNIT AND THE LIGHT REMAINED RED AND FLASHING AFTER THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277907 ↗