ARROW IPN917322Recalls & reported problems
Teleflex Incorporated · EZ-I(R) 25mm Needle + Stabilizer Kit · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902170344), received between Apr 5, 2023 and Jun 6, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2023Material Separation; Material Separation
IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE "AN IO DEVICE, THE HUB BROKE FREE FROM THE NEEDLE LEAVING THE NEEDLE IN THE PATIENT'S TIBIA". ADDITIONAL INFORMATION STATES THAT THE BEDSIDE NURSE HAD ATTEMPTED TO REMOVE THE IO WITH A 10ML SYRINGE WITHOUT SUCCESS FROM THE RIGHT TIBIA. THE NEEDLE WAS NOT REMOVED SUCCESSFULLY AS "THE HUB PULLED OFF. [THE NURSE] ATTEMPTED TO GRIP THE PIECE OF THE NEEDLE EXTENDING ABOVE THE SKIN AND THAT BROKE OFF AS WELL". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17071257 ↗MalfunctionApr 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE OPERATOR "ATTEMPTED TO ESTABLISH A HUMERAL IO, WHICH HE STATED HE FELT A POP, BUT THEN HE WAS UNABLE TO UNTHREAD THE STYLET FROM THE HOLLOW NEEDLE. HE THOUGHT HE MESSED UP THE PROCEDURE THEN WENT STRAIGHT TO TIBIAL (W/A DIFFERENT NEEDLE). BUT, ONCE AGAIN HE WAS UNABLE TO UNTHREAD THE STYLET. OUR AMBULANCE PROVIDER ARRIVED ON SCENE, HE USED THEIR EZ-IO SYSTEM & WAS ABLE TO ESTABLISH AN IO ON THE OTHER TIBIA WITH NO ISSUES". THERE WAS NO REPORTED PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16683016 ↗MalfunctionApr 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE OPERATOR " ATTEMPTED TO ESTABLISH A HUMERAL IO, WHICH HE STATED HE FELT A POP, BUT THEN HE WAS UNABLE TO UNTHREAD THE STYLET FROM THE HOLLOW NEEDLE. HE THOUGHT HE MESSED UP THE PROCEDURE THEN WENT STRAIGHT TO TIBIAL (W/A DIFFERENT NEEDLE). BUT, ONCE AGAIN HE WAS UNABLE TO UNTHREAD THE STYLET. OUR AMBULANCE PROVIDER ARRIVED ON SCENE, HE USED THEIR EZ-IO SYSTEM & WAS ABLE TO ESTABLISH AN IO ON THE OTHER TIBIA WITH NO ISSUES". THERE WAS NO REPORTED PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682937 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.