ARROW IPN917347Recalls & reported problems
Teleflex Incorporated · EZ-IO(R) 45mm Needle Set · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902170634), received between Apr 19, 2021 and Jun 28, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Detachment of Device or Device Component1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2022Break; Break
MEDWATCH# (B)(4). THE PATIENT EXPERIENCED A CARDIAC ARREST AND THE PATIENT DID NOT HAVE VASCULAR ACCESS. THE TEAM ASSESSED THE SITUATION AND DECIDED THE PATIENT WOULD BENEFIT FROM AN INTRAOSSEOUS NEEDLE. THE CRITICAL CARE NURSE USED THE EZ-IO POWER DRIVER AND PLACED AN EZ-IO 45 MM NEEDLE IN THE PATIENT'S PROXIMAL TIBIA. THE RN FOLLOWED THE MANUFACTURER'S INSTRUCTIONS FOR PLACEMENT. APPROXIMATELY 5 HOURS LATER, THE PATIENT'S STATUS CHANGED AND THE IO WAS NO LONGER NEEDED. THE CRITICAL CARE NURSE BEGAN THE REMOVAL PROCEDURE PER THE MANUFACTURER'S INSTRUCTIONS FOR REMOVAL. AFTER THE NEEDLE WAS REMOVED, THE RN NOTICED THE NEEDLE WAS NOT INTACT AND OVER ONE INCH OF THE NEEDLE REMAINED IN THE PATIENT'S TIBIA. THE NEEDLE HAD BROKEN APPROXIMATELY 0.125 INCHES BELOW THE YELLOW HUB. THE BROKEN NEEDLE PART WAS REMOVED. THE PATIENT EXPIRED AS A RESULT OF CARDIAC ARREST AND COMORBIDITIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14842934 ↗MalfunctionOct 27, 2021Break; Break
EMS USED 45MM IN TIBIA AND BURIED IT (SEE PHOTO ATTACHED). WANTED YOU TO KNOW BECAUSE IT SEEMS LIKE EMS COULD BENEFIT FROM TRAINING. CCU DID NOT KNOW WHAT SERVICE PUT NEEDLE IN BUT SAID IT WAS ONE OF TWO. ALSO, CCU COULD BENEFIT ON REMOVAL EDUCATION. I ADVISED ON WHAT TO DO BUT THEY SAID THEY TRIED AND COULD NOT REMOVE. I TOLD THEM TO CONSULT ORTHO FOR BETTER TOOL TO REMOVE. NURSE I SPOKE TO DID NOT KNOW IF IO EVER WORKED ALL HE KNEW IS THAT THE HUB BROKE WHEN THEY TRIED TO REMOVE. PATIENT CONDITION IS FINE. ADDITIONAL INFORMATION: THE BROKEN PART WAS REMOVED BY A PHYSICIAN USING A CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12703947 ↗MalfunctionApr 21, 2021Separation Problem; Separation Problem
CUSTOMER CONTACTED CS ON MARCH 17TH STATING THAT THEY HAD ATTEMPTED TO USE A NEEDLE ON A PATIENT THAT WAS IN CARDIAC ARREST. THEY NOTICED THAT THE NEEDLE HAD BEEN BONDED TOGETHER SO THEY WERE UNABLE TO USE IT. I REACHED OUT TO THE CUSTOMER ON MARCH 18TH BUT DID NOT RECEIVE A RESPONSE UNTIL APRIL 7TH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11699955 ↗MalfunctionApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER IO NEEDLE INSERTED, THE PATIENT WAS TRANSFERRED BACK TO WARD AND THE HEAD NURSE FOUND THE NEEDLE WAS SEPARATED FROM THE HUB. THE NEEDLE WAS REMOVED BY AN ORTHOPEDICS PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11684648 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.