ARROW IPN033711Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816000011942), received between Dec 17, 2018 and May 14, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K141117); they may or may not involve this specific model.

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

• MalfunctionMay 14, 2024Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED BY CLINICAL STAFF THAT: "STYLET COULD NOT BE REMOVED FROM CATHETER". THE PATIENTS CURRENT CONDITION IS REPORTED AS "DECEASED". THE PATIENT WAS BEING TREATED FOR A REPORTED "CARDIAC ARREST". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CLINICAL STAFF.

  Patient problems: Insufficient Information

  MAUDE report 19310330 ↗
• MalfunctionMay 14, 2024Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED BY CLINICAL STAFF THAT: "STYLET COULD NOT BE REMOVED FROM CATHETER".THE PATIENTS CURRENT CONDITION IS REPORTED AS "DECEASED". THE PATIENT WAS BEING TREATED FOR A REPORTED "INTERNAL TRAUMA". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CLINICAL STAFF.

  Patient problems: Insufficient Information

  MAUDE report 19310098 ↗
• InjuryApr 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "NEEDLE WOULDN'T SEPERATE FROM THE STYLET". TO CONTINUE THERAPY, ANOTHER SITE WAS USED. PATIENT'S CURRENT CONDITION IS "CRICITAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067306 ↗
• MalfunctionFeb 20, 2024Material Separation; Material Separation

  THE REPORT STATES "THE EMT-P STATED SHE FOLLOWED THE PROPER LANDMARKING AND INSERTION OF A 25MM NEEDLE IN THE PROXIMAL TIBIA AND THE NEEDLE SEPARATED FROM THE HUB AT THE POINT WHERE THE NEEDLE AND HUB MEET. THE HUB STAYED INTACT BUT CAME OFF OF THE NEEDLE. SHE THEN REMOVED THE NEEDLE AND PERFORMED ANOTHER INSERTION ON THE OPPOSITE TIBIA WITH A 45MM NEEDLE WITH THE SAME ISSUE. AT THIS POINT A SECOND EMT-P STEPPED IN AND INSERTED ANOTHER 25MM NEEDLE IN THE TIBIA WITHOUT PROBLEM. A FEW MINUTES AFTER OUR CALL I RECEIVED AN EMAIL AND CALL FROM THE QUALITY & CLINICAL MANAGER STATING SHE INTERVIEWED THE 2ND EMT-P AND FOUND THE 1ST EMT-P WAS INSERTING ON THE LATERAL SIDE OF THE TIBIA INSTEAD OF THE MEDIAL. THE MANAGER NOW BELIEVES THIS IS A USER ISSUE AND NOT A PRODUCT ISSUE". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL". SEE ASSOCIATED MDR #3011137372-2024-00031.

  Patient problems: Insufficient Information

  MAUDE report 18739186 ↗
• InjuryJan 15, 2024Material Separation; Material Separation

  IO INSERTED BY EMS, REMOVED BY NURSING STAFF. 10CC SYRINGE ATTACHED AND PULLED OUT, THE PLASTIC APPEARS TO HAVE BROKEN OFF FROM THE METAL NEEDLE, AND THE METAL NEEDLE REMAINED IN THE PATIENT. NEEDLE REMOVED WITH KELLY CLAMPS. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". THERE WAS NO REPORTED PATIENT INJURY OR CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18510120 ↗
• MalfunctionOct 23, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT WHILE WORKING ON A PEDIATRIC CODE FOR AN INFANT DROWNING, "[THE USER] ATTEMPTED AN INSERTION IN THE PROXIMAL TIBIA, INSERTION WAS SUCCESSFUL. WHEN ATTEMPTING TO THREAD OUT THE STYLET THEY FOUND IT TO BE STUCK. [THE USER] ATTEMPTED TO REMOVE WITH A SIGNIFICANT AMOUNT OF MUSCLE WITH NO SUCCESS, TWO OTHER PARTNERS ATTEMPTED, NO SUCCESS. THEY EVEN WENT AS FAR AS TO USE TRAUMA SCISSOR AS A PLIERS AND STILL COULD NOT GET IT TO COME APART. THEY HAVE A SHORT TRANSPORT TIME AND ARRIVED AT THE HOSPITAL BEFORE A SECOND INSERTION WAS ATTEMPTED". THE PATIENT STATUS WAS REPORTED AS "DECEASED". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT IT WAS UNKNOWN HOW LONG IT WAS FROM THE PATIENT SUFFERING CARDIAC ARREST TO WHEN IO ACCESS WAS ATTEMPTED, THE PATIENT WAS DOWN FOR AN UNKNOWN AMOUNT OF TIME PRIOR TO EMERGENCY SERVICES' ARRIVAL. THERE WAS NO VASCULAR ACCESS ATTEMPTED PRIOR TO THE FIRST IO ATTEMPT. IT WAS FURTHER REPORTED, FROM THE FAILED REMOVAL OF THE STYLET TO GAINING VASCULAR ACCESS AT THE HOSPITAL, THE TIME DELAY WAS APPROXIMATELY 10 MINUTES. ASIDE FROM THE REPORT OF A PEDIATRIC CODE FOR AN INFANT DROWNING, THE CUSTOMER DID NOT PROVIDE INFORMATION

  Patient problems: Needle Stick/Puncture

  MAUDE report 17987159 ↗
• MalfunctionOct 13, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT "IO ACCESS WAS ATTEMPTED AT THE R PROXIMAL TIBIA SITE WITH A 25MM IO NEEDLE BY [CLINICIAN]. THE NEEDLE WAS UNABLE TO BE REMOVED. MULTIPLE PROVIDERS ATTEMPTED MULTIPLE TIMES TO REMOVE THE NEEDLE UNSUCCESSFULLY. IT WAS OPTED TO LEAVE THE IO AS IS AND MOVE TO THE L HUMERAL HEAD WITH A 45MM IO NEEDLE. ACCESS WAS ESTABLISHED SUCCESSFULLY AT THIS SITE WITH NO COMPLICATIONS". NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN" AS THIS DEVICE WAS OPERATED BY THE FIRE DEPARTMENT WHICH TRANSFERRED THE PATIENT TO THE NEXT PHASE OF CARE IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930310 ↗
• MalfunctionDec 17, 2018Component Missing; Connection Problem

  PATIENT AT OUTPATIENT FACILITY BECAME UNRESPONSIVE. 911 CALLED TO RESPOND TO A PATIENT IN CARDIAC ARREST. STAFF MEMBER WENT TO PTS LEGS TO START AN EASY IO ON PTS LEFT LOWER LEG. THE EASY IO WAS ASSEMBLED AND DRILL STARTED. WHEN THE STAFF MEMBER WITHDREW THE NEEDLE CATH IT WAS DISCOVERED THERE WAS NO INNER CATH. HE WAS UNABLE TO CONNECT THE IV BECAUSE THERE WAS NO EZ-CONNECT EXTENSION SET INCLUDED. THIS RESULTED IN REMOVING THIS FROM THE PATIENT'S LEG AND REPEATING THE PROCESS WITH A NEW PACKAGE WHICH INCLUDED THE ENTIRE CONNECTION SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141117. One submission often covers many models, so check the product and lot details in each record.

• Z-0689-2020 · Oct 8, 2019 · Open, Classified
  Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides
• Z-0690-2020 · Oct 8, 2019 · Open, Classified
  Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides
• Z-0688-2020 · Oct 8, 2019 · Open, Classified
  Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides