ARROW IPN033767Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816000011980), received between Aug 21, 2023 and Jan 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break; Material Separation

  IT WAS REPORTED THAT: "THE MD AT THE EMERGENCY CENTER INSERTED THE EZ-IO NEEDLE INTO THE RIGHT UPPER HUMERUS OF THE PATIENT IN CARDIOPULMONARY ARREST, IN ORDER TO INJECT MORE VOLUME OF THE MEDICAL AGENT. HOWEVER, THE CONDITION OF THE PATIENT DID NOT IMPROVE AND FINALLY DIED. WHEN A TRAINEE DOCTOR WAS REMOVING THE NEEDLE, THE CANNULA BROKE, THE ISSUE OCCURRED AFTER THE PATIENT DIED. THE CUSTOMER STATED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT'S DEATH."

  Patient problems: Insufficient Information

  MAUDE report 23942657 ↗
• MalfunctionMar 6, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT: MALFUNCTION - DURING OR AFTER USE. ADDITIONAL INFORMATION: PROPOFOL AND FENTANYL WERE INFUSING THROUGH IO WHEN IT STARTED LEAKING. USER ATTEMPTED TO UNDO THE EXTENSION SET AND REATTACH BUT CONTINUED TO LEAK, THEN A 10CC SYRINGE WAS ATTACHED TO THE IO WHILE THEY WENT TO GET A NEW EXTENSION SET BUT LEAK CONTINUED THROUGH A CRACK IN THE IO. THE USER FELT IT MAY BE MARROW LEAKING. THE PATIENT DID HAVE A CENTRAL LINE WHICH HAD MEDICATION RUNNING AT THE TIME AND THEY ATTEMPTED TO INSERT A PERIPHERAL LINE BUT FAILED. MEDICATION WAS SWAPPED OUT OF THE CENTRAL LINE FOR THE SEDATION AND THE IO WAS REMOVED. IMPACT: THE PATIENT WAS NOT SEDATED WHEN THEY SHOULD HAVE BEEN WHICH CAUSED DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 18847860 ↗
• InjuryAug 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT "THERE WAS AN INCIDENT A FEW MONTHS AGO WHERE SOMEONE PUSHED MEDS THROUGH A DISLODGED OR INCORRECTLY PLACED PROXIMAL HUMERUS IO THAT CAUSED THE PATIENT TO LOSE THEIR ARM". THE CURRENT STATUS OF THE PATIENT IS REPORTED AS "FINE". PER THE CUSTOMER, "75% OF THEIR NURSES ARE FRESH OUT OF NURSING SCHOOL AND MOST DON'T KNOW HOW TO CORRECTLY PLACE AN IO". EDUCATION CLASSES WERE PROVIDED TO THE STAFF.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17590571 ↗

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-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
• 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