NIO NIO-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290008325059), received between Sep 28, 2018 and Apr 2, 2025 — classified as 2 deaths, 6 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 5, 2025Open, Classified

   Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

   Z-2118-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathApr 2, 2025Mechanical Problem; Mechanical Problem

  PATIENT WAS IN CARDIAC ARREST WITH CPR BEING PERFORMED. CREW ARRIVED AND TOOK OVER CPR. IV WAS ATTEMPTED AND FAILED. NIO WAS BROUGHT OUT, SITE LOCATED AND WHEN WE SPUN THE TOP ON THE NIO TO UNLOCK IT, IT WAS TIGHT TO TURN. PRESSURE PLACED WITH DOMINANT HAND, OTHER HAND STABILIZING NIO. NIO DID NOT DEPLOY, SECOND CREWMEMBER ATTEMPTED TO DEPLOY IT AND IT DID NOT WORK. SECOND NIO WAS BROUGHT OUT AND THE SAME THING HAPPENED. TOP WAS TIGHT TO SPIN AND IT DID NOT DEPLOY FOR EITHER THE RN OR AEMT. MANUAL IO WAS PLACED IN THIS PATIENT FIRST ATTEMPT. CPR CONTINUED. PATIENT DIED. ONE OF THE NIO THAT DID NOT DEPLOY WAS BROUGHT BACK TO THE STATION AND IS CURRENTLY BEING SENT BACK WITH THE PROVIDED SHIPPING LABEL.

  Patient problems: Insufficient Information

  MAUDE report 21756448 ↗
• MalfunctionApr 2, 2025Firing Problem; Firing Problem

  COMPLAINT DESCRIPTION FROM CUSTOMER ON MARCH 30 2025: "PATIENT WAS IN CARDIAC ARREST WITH CPR BEING PERFORMED. CREW ARRIVED, TOOK OVER CPR. IV WAS ATTEMPTED AND FAILED. NIO WAS BROUGHT OUT, SITE LOCATED AND WHEN WE SPUN THE TOP ON THE NIO TO UNLOCK IT, IT WAS TIGHT TO TURN. PRESSURE PLACED WITH DOMINANT HAND, OTHER HAND STABILIZING NIO. NIO DID NOT DEPLOY, SECOND CREWMEMBER ATTEMPTED TO DEPLOY IT AND IT DID NOT WORK. SECOND NIO WAS BROUGHT OUT AND THE SAME THING HAPPENED. TOP WAS TIGHT TO SPIN AND IT DID NOT DEPLOY FOR EITHER THE RN OR EMT. MANUAL IO WAS PLACED IN THIS PATIENT FIRST ATTEMPT. CPR CONTINUED. PATIENT DIED. ONE OF THE NIO THAT DID NOT DEPLOY WAS BROUGHT BACK TO THE STATION AND IS CURRENTLY BEING SENT BACK WITH THE PROVIDED SHIPPING LABEL.

  Patient problems: Insufficient Information

  MAUDE report 21750879 ↗
• DeathApr 2, 2025Firing Problem; Firing Problem

  COMPLAINT DESCRIPTION FROM CUSTOMER ON (B)(6) 2025: "PATIENT WAS IN CARDIAC ARREST WITH CPR BEING PERFORMED. CREW ARRIVED, TOOK OVER CPR. IV WAS ATTEMPTED AND FAILED. NIO WAS BROUGHT OUT, SITE LOCATED AND WHEN WE SPUN THE TOP ON THE NIO TO UNLOCK IT, IT WAS TIGHT TO TURN. PRESSURE PLACED WITH DOMINANT HAND, OTHER HAND STABILIZING NIO. NIO DID NOT DEPLOY, SECOND CREWMEMBER ATTEMPTED TO DEPLOY IT AND IT DID NOT WORK. SECOND NIO WAS BROUGHT OUT AND THE SAME THING HAPPENED. TOP WAS TIGHT TO SPIN AND IT DID NOT DEPLOY FOR EITHER THE RN OR EMT. MANUAL IO WAS PLACED IN THIS PATIENT FIRST ATTEMPT. CPR CONTINUED. PATIENT DIED. ONE OF THE NIO THAT DID NOT DEPLOY WAS BROUGHT BACK TO THE STATION AND IS CURRENTLY BEING SENT BACK WITH THE PROVIDED SHIPPING LABEL.

  Patient problems: Insufficient Information

  MAUDE report 21750369 ↗
• MalfunctionNov 10, 2024Firing Problem; Firing Problem

  COMPLAINT DESCRPTION FROM CUSTOMER ON OCTOBER 15, 2024: "WE RECENTLY HAD AN NIO ADULT DEVICE MALFUNCTION DURING A CODE EVENT. WE STOCK THESE IN OUR CODE CARTS AND WHEN MY TEAM MEMBER ATTEMPTED TO INSERT THE DEVICE, FOLLOWING THE IFU, IT DEPLOYED, WITH DELAY, AND ACTUALLY FELL APART. FOLLOWS IS THE COMMUNICATION I RECEIVED FROM MY COLLEAGUE: I WENT TO PLACE AN NIO DURING A CODE AND IT WAS VERY DIFFICULT TO DEPLOY THE NIO. I AM COMFORTABLE PLACING THE NIO AND USING THE NIO DEVICE. THE DEVICE I USED WAS FROM THE CRASH CART AND THERE ARE NO EXTRAS IN THE CRASH CART WHEN SOMETHING LIKE THIS OCCURS. HERE WAS THE SEQUENCE: I HAD UNLOCKED IT, UNCAPPED IT, WAS STABILIZING IT AND DID THE SQUEEZE AND FINALLY, AFTER WHAT SEEMED LIKE AN ETERNITY IN A BAD SITUATION, IT DID DEPLOY BUT AT THE SAME TIME, THE ENTIRE NIO APPARATUS EXPLODED. LITERALLY. I DON'T KNOW WHAT TO SAY. I DID SAVE IT FOR YOU IF YOU WANT TO TAKE A LOOK, BUT THAT IS SERIOUSLY WHAT HAPPENED. I CAME BACK TO THE OFFICE AFTER I WAS ORGANIZED AND GRABBED ANOTHER NIO JUST TO SEE IF IT WAS ME AND NOPE. IT DEPLOYED EASY JUST LIKE IT SHOULD. NO ISSUES AND NO EXPLOSION. NO HARM WAS DONE TO THE PATIENT OTHER THAN A DELAY IN VASCULAR ACCESS

  Patient problems: Insufficient Information

  MAUDE report 20648712 ↗
• MalfunctionJun 26, 2024Mechanical Problem; Mechanical Problem

  DESCRIPTION PROVIDED BY THE CUSTOMER: "PATIENT WAS S/P CARDIAC ARREST. CODE TEAM MEMBER ARRIVED AND WAS ASKED TO PLACE AN IO IN THE PATIENT'S LEG. PATIENT WAS PREPPED AND SCRUBBED IN PROXIMAL LEFT TIBIA. IO END CAP WAS REMOVED, AND STYLET WAS TURNED TO ACTIVATE THE NEEDLE INTO POSITION. UPON PLACING PRESSURE INTO LEG AND PULLING TRIGGER, IO FAILED TO DEPLOY FULLY INTO THE BONE. CANNULA WAS REMOVED. SECOND ATTEMPT WAS MADE IN THE PROXIMAL RIGHT TIBIA IN SIMILAR FASHION. SECOND IO WAS PULLED FROM CODE TEAM BAG AND WAS A SEPARATE BUT SIMILAR MODEL. UPON DEPLOYING INTO THE BONE, INNER CANNULA WAS UNABLE TO BE REMOVED FROM THE OUTER IO CANNULA AND THUS WAS UNABLE TO BE USED APPROPRIATELY. AS PATIENT HAD CENTRAL LINE ACCESS AT THIS TIME, ATTEMPTS TO PLACE IO WERE HALTED AND WOUNDS DRESSED WITH TEGADERM."

  Patient problems: Insufficient Information

  MAUDE report 19611823 ↗
• MalfunctionOct 18, 2023Failure to Fire; Failure to Fire

  COMPLAINT DESCRIPTION FROM CUSTOMER ON (B)(6) 2023. "VAT NURSE OPENED PACKAGE, UNLOCKED DEVICE BY TWISTING TOP, SQUEEZED DOWN AND THE NEEDLE DID NOT DEPLOY. SECOND NURSE STEPPED IN AND ATTEMPTED TO DEPLOY NEEDLE AND GOT A NEGATIVE RESPONSE. THEY OPENED ANOTHER UNIT, FOLLOWED THE SAME STEPS, AND SUCCESSFULLY DEPLOYED NEEDLE INTO PATIENT. THERE WAS A ONE-TO-TWO-MINUTE DELAY BETWEEN START AND DEPLOYMENT BECAUSE OF THIS INCIDENT. BOTH NURSES HAVE BEEN TRAINED ON THE DEVICE AND HAVE SUCCESSFULLY USED IT IN THE PAST".

  Patient problems: Insufficient Information

  MAUDE report 17955292 ↗
• MalfunctionJun 1, 2022Component Missing; Component Missing

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER ON (B)(6) 2022: DESCRIBE THE EVENT OR PROBLEM: IO (INTRAOSSEOUS NEEDLE) WAS PLACED TO DELIVER LIFESAVING MEDICATIONS. THERE WAS NO CATHETER WITH THE NEEDLE. THIS CAUSED A DELAY WITH PATIENT GETTING MEDICATIONS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TO DELIVER PRESSORS AND RSI MEDICATIONS. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565969 ↗
• MalfunctionSep 28, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NIO DEPLOYED IN THE LEFT TIBIA OF THE PATIENT. AFTER FLUSHING, IT WAS REPORTED THAT BONE MARROW WAS PRESENT AND NEEDLE PLACEMENT IN THE MARROW CAVITY WAS CONFIRMED. SEVERAL MINUTES AFTER DEPLOYMENT, PATIENT'S LEG APPEARED SWOLLEN IN COMPARISON TO HIS RIGHT LEG. THE PATIENT BECAME RESPONSIVE TO TREATMENTS AFTER ACCESS VIA DIFFERENT IO NEEDLE WAS PLACED.

  Patient problems: Swelling

  MAUDE report 7917513 ↗