ARROW IPN917337Recalls & reported problems
Teleflex Incorporated · EZ-IO® 15mm Needle + Stabilizer Kit · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902170498), received between Sep 1, 2021 and May 18, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Flush” (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
- Difficult to Flush2
- Failure to Prime2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2023Difficult to Flush; Failure to Prime; Difficult to Flush; Failure to Prime
IT WAS REPORTED THAT DURING RESUSCITATION EFFORTS ON A PATIENT THAT ARRIVED TO THE FACILITY IN FULL CARDIOPULMONARY ARREST, THE USER WAS UNABLE TO PRIME AND FLUSH THE EXTENSION SET OF THE IO. AS A RESULT, A 2ND EXTENSION SET WAS OPENED BUT WAS ALSO UNABLE TO BE PRIMED AND FLUSHED. ULTIMATELY, AN IO WAS PLACED SUCCESSFULLY WITH THE USE OF A COMPETITOR DEVICE. DESPITE BEST EFFORTS, THE PATIENT EXPIRED. ADDITIONAL INFORMATION STATES THAT THE PHYSICIAN DOES NOT ASSERT THAT THE INABILITY TO FLUSH THE EXTENSION SET CONTRIBUTED TO THE PATIENT'S DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16953367 ↗MalfunctionMay 18, 2023Difficult to Flush; Failure to Prime; Difficult to Flush; Failure to Prime
IT WAS REPORTED THAT DURING RESUSCITATION EFFORTS ON A PATIENT THAT ARRIVED TO THE FACILITY IN FULL CARDIOPULMONARY ARREST, THE USER WAS UNABLE TO PRIME AND FLUSH THE EXTENSION SET OF THE IO. AS A RESULT, A 2ND EXTENSION SET WAS OPENED BUT WAS ALSO UNABLE TO BE PRIMED AND FLUSHED. ULTIMATELY, AN IO WAS PLACED SUCCESSFULLY WITH THE USE OF A COMPETITOR DEVICE. DESPITE BEST EFFORTS, THE PATIENT EXPIRED. ADDITIONAL INFORMATION STATES THAT THE PHYSICIAN DOES NOT ASSERT THAT THE INABILITY TO FLUSH THE EXTENSION SET CONTRIBUTED TO THE PATIENT'S DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16953313 ↗MalfunctionSep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE NEEDLE COVER WAS OFF THE NEEDLE WHILE IN THE PACKAGE AND STRUCK THE EMPLOYEE THROUGH THE PACKAGE WHILE UNOPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12407039 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.