ARROW IPN917316Recalls & reported problems
Teleflex Incorporated · EZ-IO(R) 25mm Needle Set · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902170320), received between Mar 30, 2022 and Jul 17, 2023 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT AFTER INSERTION ON A CRITICALLY ILL MULTI-SYSTEM TRAUMA PATIENT, THE USER WAS UNABLE TO REMOVE THE STYLET. AS A RESULT, A NEW EZ-IO WAS INSERTED SUCCESSFULLY AND USED WITHOUT ISSUE. THE PATIENT ULTIMATELY EXPIRED "IN OR 1-2 HOURS AFTER HAND-OFF IN ED". ADDITIONAL INFORMATION STATES THAT THE CAUSE OF DEATH WAS "EXSANGUINATION". IT IS ALSO REPORTED THAT "THE EZ-IO FAILURE DOES NOT APPEAR TO BE THE DIRECT CAUSE OF THIS PATIENT'S DEATH".
Patient problems: Foreign Body In Patient
MAUDE report 17335123 ↗MalfunctionMar 30, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
CUSTOMER CALLED STATING THAT ONCE THE EZ-IO NEEDLE WAS INSERTED THEY WERE UNABLE TO REMOVE THE STYLET. THEY REMOVED THE ENTIRE NEEDLE AND USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE. PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13956687 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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