ARROW IPN033708Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816000011881), received between Feb 14, 2018 and May 17, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Fitting Problem; Physical Resistance/Sticking; Fitting Problem; Physical Resistance/Sticking

  IT WAS REPORTED "THE INNER NEEDLE CANNOT BE PULLED OUT. USED ON A PATIENT AND NO PATIENT HARM. THE PRODUCT HAS BEEN DISCARDED AND NEEDS TO BE REPLACED WITH A NEW SET." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339920 ↗
• InjuryMay 8, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY CLINICAL STAFF AT THE FACILITY THAT: "POST TRAUMA PATIENT, CODED IN ICU, MULTIPLE FAILED CVC ATTEMPTS, IO PLACED BY RN IN TIBIA WITH PHYSICIANS PRESENT, ROSC ACHIEVED, IO USED FOR MEDS AND BLOOD ADMINISTRATION FOR MULTIPLE HOURS, PATIENT LATER DEVELOPED COMPARTMENT SYNDROME AND WENT TO OR FOR FASCIOTOMY, BUT THEN UNDERWENT COMPLICATIONS POST OP AND IS DECEASED NOW. THE FACILITY HAS STATED THAT THE ISSUE WAS USER-ERROR AS THE IO WAS REPORTED TO THE REP TO HAVE BEEN PLACED MID-SHAFT ON THE TIBIA." IT WAS ALSO REPORTED THAT "MULTIPLE ISSUES COMPILED THROUGHOUT HIS STAY AND THAT HE WAS NONCOMPLIANT DURING HIS STAY." THE PATIENT'S DEATH WAS AT LEAST 6 HOURS POST THE INCIDENT BUT THE FACILITY DID NOT DISCLOSE THE EXACT TIMELINE.

  Patient problems: Ischemia; Reduced Blood Flow

  MAUDE report 19269831 ↗
• InjuryApr 29, 2024Material Separation; Material Separation

  IT WAS REPORTED "AN IO WAS USED ON A PATIENT IN OUR EMERGENCY DEPARTMENT. IT WAS LEFT IN FOR 24HRS AND REMOVED. WHEN THE NURSES ATTEMPTED TO REMOVE IT, THEY COULD NOT GET IT OUT. MULTIPLE PEOPLE TRIED AND FINALLY AN ER NURSE CAME UP TO THE FLOOR TO REMOVE IT. WHEN IT FINALLY LOOSENED TO COME OUT, THE NEEDLE WAS BROKEN OFF AND STAYED INSIDE THE PATIENT". ADDITIONAL INFORMATION REPORTS, "THE PATIENT HAS NOT BEEN MEANINGFULLY RESPONSIVE SINCE ARRIVAL TO THE HOSPITAL. THIS PATIENT HAS BEEN RECOMMENDED TO HOSPICE CARE FOR REASONS UNRELATED TO THIS EVENT". THE PATIENT RECEIVED AN XRAY BUT THE PRODUCT WAS NOT REMOVED FROM THE PATIENT. NO PATIENT HARM OR INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19200584 ↗
• InjuryNov 30, 2023Positioning Failure; Patient-Device Incompatibility; Material Twisted/Bent; Positioning Failure; Patient-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT: ON (B)(6) 2023, AN ATTEMPT WAS MADE TO CREATE AN I.O. ACCESS IN THE TIBIA WITH A 25 MM NEEDLE IN A 19-YEAR-OLD PATIENT. AFTER INSERTION DURING DRILLING, THE NEEDLE STARTED TO ROTATE UNEVENLY AT THE FRONT AND SCRAPED THE PERIOSTEUM. THERE WAS SOFT TISSUE DAMAGE. ON THE SECOND ATTEMPT, DIFFERENT SIDE TIBIA, SAME PROBLEM. ASSOCIATED TO 3011137372-2023-00251 AND 3011137372-2023-00250.

  Patient problems: Hematoma; Pain; Skin Tears

  MAUDE report 18235883 ↗
• InjuryNov 30, 2023Positioning Failure; Patient-Device Incompatibility; Material Twisted/Bent; Positioning Failure; Patient-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2023, AN ATTEMPT WAS MADE TO CREATE AN I.O. ACCESS IN THE TIBIA WITH A 25 MM NEEDLE IN A 19-YEAR-OLD PATIENT. AFTER INSERTION DURING DRILLING, THE NEEDLE STARTED TO ROTATE UNEVENLY AT THE FRONT AND SCRAPED THE PERIOSTEUM. THE COLLEAGUES WHO WERE ON SITE REPORTED THAT THERE WAS SOFT TISSUE DAMAGE. ON THE SECOND ATTEMPT, DIFFERENT SIDE TIBIA, SAME PROBLEM.

  Patient problems: Hematoma; Pain; Skin Tears

  MAUDE report 18235870 ↗
• MalfunctionFeb 14, 2018Device Operates Differently Than Expected

  ARROW EZ-IO 25MM 15 GA NEEDLE WAS INSERTED INTO PATIENT'S TIBIA. AFTER PLACEMENT, IT WAS NOTED THAT THERE WAS NOT A CATHETER, ONLY A NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272647 ↗

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-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
• 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