ARROW IPN917317Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902170337), received between Jan 28, 2021 and May 4, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE "PROVIDER WAS NOT ABLE TO REMOVE NEEDLE AFTER INSERTION". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16872752 ↗
• MalfunctionMar 14, 2023Failure to Disconnect; Failure to Disconnect

  REPORTED ISSUE: PARAMEDIC INSERTED THE IO NEEDLE IN TIBIA BUT COULD NOT REMOVE THE NEEDLE. ANOTHER IO WAS STARTED WITHOUT AN ISSUE. THE "PATIENT'S" DEATH IS REPORTED AS NON-CONTRIBUTORY TO THE DEVICE MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 16539136 ↗
• MalfunctionJul 11, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ALS CREW DISPATCHED TO A PRI1 SEIZURE PATIENT, AND ARRIVED TO FIND A 65 Y/O FEMALE PATIENT WITH AMS, GCS 9. PATIENT HAS NO KNOWN HISTORY OF SEIZURES, AND FAMILY ON SCENE PROVIDED HISTORY OF THE EVENT. PATIENT WAS MOVED TO THE AMBULANCE FOR EMERGENT TRANSPORT TO HOSPITAL. SHORTLY AFTER TRANSPORT STARTED, THE PATIENT STARTED TO DETERIORATE, BECOMING MORE LETHARGIC AND HYPOTENSIVE AND THEN GOING PULSELESS. CPR WAS STARTED, AND CARDIAC ARREST PROTOCOL STARTED. 25MM EZ-IO NEEDLE WAS PLACED IN THE PATIENT'S RIGHT PROXIMAL TIBIA, BUT THE IO NEEDLE WAS UNABLE TO BE USED BECAUSE IT WOULD NOT UNTHREAD. THE NEEDLE PART WOULD NOT UNSCREW FROM THE METAL CATHETER AND THEREFORE WAS UNABLE TO BE REMOVED IN ORDER TO ATTACH THE IV TUBING. A SECOND IO WAS STARTED IN THE PATIENT'S LEFT PROXIMAL TIBIA WITHOUT ISSUE, AND FLUIDS/MEDICATIONS WERE STILL ABLE TO BE ADMINISTERED. PATIENT REMAINED IN CARDIAC ARREST FOR THE REMAINDER OF TRANSPORT, AND CARE TRANSFERRED TO HOSPITAL STAFF.

  Patient problems: Insufficient Information

  MAUDE report 14983181 ↗
• MalfunctionJul 11, 2022Complete Loss of Power; Complete Loss of Power

  THE IO DRILL FAILED ON SCENE FOR A CARDIAC ARREST. WAS INITIATING AN IO FOR MEDICATION ADMINISTRATION AND WHILE INSERTING THE IO THE DRILL BATTERY DIED. WAS UNABLE TO COMPLETE TASK IN A TIMELY MANNER DUE TO ANOTHER CREW MEMBER HAVING TO GO GET ANOTHER IO DRILL FROM THE AMBULANCE OUTSIDE. MEDICATION ADMINISTRATION WAS DELAYED IN THIS CARDIAC ARREST. RESUSCITATION EFFORTS WERE DISCONTINUED ON SCENE. THE PATIENT WAS IN CARDIAC ARREST AND IS DECEASED. MANUAL INSERTION ATTEMPTED BUT NEEDED DRILL TO COMPLETE. IT WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981108 ↗
• MalfunctionApr 15, 2022Component Missing; Component Missing

  WHEN REMOVING THE NEEDLE FROM THE PACKAGING AND INSERTING IT, THEY NOTED THAT THEY COULD NOT UNSCREW THE NEEDLE FROM THE SHAFT. LOOKING MORE CLOSELY, I NOTICED THAT THE SHAFT WAS NOT PRESENT AND THAT IT DID NOT COME WITH THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE. ANOTHER NEEDLE SET WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119302 ↗
• MalfunctionJan 11, 2022Break; Break

  EMS MEDIC WAS INSERTING 25MM IO INTO PATIENT AND APPARENTLY IT BROKE DURING INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 13225236 ↗
• MalfunctionSep 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON THE EZIO 25MM 15GA NEEDLE SET THE PARAMEDIC REPORTED THAT THE HUB WOULD NOT COME OFF THE NEEDLE AND THE EXTENSION SET HAS A CRUSHED/MELTED END RESULTING IN UNABLE TO USE. THE PATIENT WAS IN CARDIAC ARREST. IO ACCESS WAS ACHIEVED WITH A SECOND DEVICE. THE DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE PROBLEM WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE HUB/NEEDLE THE DEVICE WOULD NOT SEPARATE. THE FIRST DEVICE WAS LEFT IN THE PATIENT AFTER THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467746 ↗
• MalfunctionAug 19, 2021Separation Problem; Separation Problem

  E80 RESPONDED TO A CARDIAC ARREST. THEY ATTEMPTED TO PLACE A 25MM IO NEEDLE AND ONCE THEY ATTEMPTED TO REMOVE THE INNER CANNULA, IT WOULD NOT UNSCREW FROM THE BASE. ACCORDING TO ACCOUNT THIS IS NOW THE 3RD TIME IT HAS HAPPENED. UPDATE:THEY DID PLACE A 15 MM IO NEEDLE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341885 ↗
• MalfunctionAug 19, 2021Separation Problem; Separation Problem

  E80 RESPONDED TO A CARDIAC ARREST. THEY ATTEMPTED TO PLACE A 25MM IO NEEDLE AND ONCE THEY ATTEMPTED TO REMOVE THE INNER CANNULA, IT WOULD NOT UNSCREW FROM THE BASE. ACCORDING TO ACCOUNT THIS IS NOW THE 3RD TIME IT HAS HAPPENED. UPDATE: THEY DID PLACE A 15 MM IO NEEDLE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341825 ↗
• MalfunctionApr 22, 2021Separation Failure; Separation Failure

  IO THAT WAS USED DURING A CARDIAC ARREST. BOTH MESSAGES REFER TO THE SAME IO. AFTER INSERTING THE IO WE WERE UNABLE TO REMOVE THE INNER CANNULA. IT WOULD NOT SEPARATE FROM THE BODY OF THE IO. I HAVE PERIODICALLY ENCOUNTERED THIS IN THE PAST. UNSURE OF THE MALFUNCTION. WHEN I INSERTED THE IO, IT WOULD NOT TWIST OFF. IT WAS AS IF THE PLASTIC WAS FUSSED TOGETHER. WE KEPT TRYING TO TWIST BUT IT WOULD JUST TWIST OUT OF PTS LEG. ONE OF THE MEMBERS SAID IT HAPPENED TO THEM BEFORE. IT WAS A MANUFACTURES DEFECT I SUPPOSE BECAUSE THAT HAD NEVER HAPPENED TO ME BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706507 ↗
• MalfunctionApr 22, 2021Separation Failure; Separation Failure

  IO THAT WAS USED DURING A CARDIAC ARREST. BOTH MESSAGES REFER TO THE SAME IO. AFTER INSERTING THE IO WE WERE UNABLE TO REMOVE THE INNER CANNULA. IT WOULD NOT SEPARATE FROM THE BODY OF THE IO. I HAVE PERIODICALLY ENCOUNTERED THIS IN THE PAST. UNSURE OF THE MALFUNCTION. WHEN I INSERTED THE IO, IT WOULD NOT TWIST OFF. IT WAS AS IF THE PLASTIC WAS FUSSED TOGETHER. WE KEPT TRYING TO TWIST BUT IT WOULD JUST TWIST OUT OF PTS LEG. ONE OF THE MEMBERS SAID IT HAPPENED TO THEM BEFORE. IT WAS A MANUFACTURES DEFECT I SUPPOSE BECAUSE THAT HAD NEVER HAPPENED TO ME BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706438 ↗
• MalfunctionJan 28, 2021Separation Failure; Separation Failure

  THERE WAS AN ISSUE WITH THE NEEDLE NOT COMING THROUGH. ADDITIONAL INFORMATION: THE PATIENT WAS IN FULL CARDIAC ARREST SO I NOTIFIED THE DOCTOR THAT I WAS GOING TO INSERT AN IO IN THE LEFT PROXIMAL TIBIA. I FELT FOR MY LANDMARK. I INSERTED THE IO NEEDLE BUT WAS UNABLE TO DETACH THE INSERTION DEVICE. THERE WAS ANOTHER IV NURSE AT THE BEDSIDE AND SHE WAS UNABLE TO DETACH AS WELL. I COULD NOT CONNECT A SYRINGE SO I GAVE A PINK NEEDLE TO THE OTHER NURSE AND SHE INSERTED IT IN THE RIGHT TIBIA. I REMOVED THE NEEDLE FROM THE LEFT TIBIA AND SAVED IT AS I BELIEVE IT WAS FAULTY. THE NURSE WAS ABLE TO GIVE THE MEDS THROUGH THE OTHER IO NEEDLE. THE PATIENT EXPIRED, HE WAS A CARDIAC ARREST IN THE ED. NO INTERVENTIONS WERE REQUIRED ANOTHER IO WAS USED WITHOUT ANY INCIDENT. THE CLINICAL COORDINATOR OF EMERGENCY SERVICES/CHIEF PARAMEDIC STATED, FROM LOOKING IN THIS I DO NOT BELIEVE THAT THIS INCIDENT WITH THE I/O HAD ANY BEARING ON THE PATIENT'S OUTCOME ANOTHER I/O WAS PLACED WITHIN MINUTES OF IDENTIFYING THE ISSUE WITH THE FIRST NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11246087 ↗