ARROW IPN033729Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816000011966), received between Nov 16, 2023 and Apr 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED "THEY REPORT INSERTING THE 15MM NEEDLE INTO THE PROXIMAL TIBIA AS DIRECTED AND BEING UNABLE TO UNSCREW THE STYLET FROM THE CANNULA. AFTER MULTIPLE PROVIDER ATTEMPTS TO UNSCREW THE STYLET, A SECOND 15MM WAS USED ON THE OPPOSITE LEG WITH SUCCESS. THE NEEDLE SET WAS RECOVERED FROM THE SHARPS SAFETY BIN AND IT WAS UNKNOWN HOW, BUT EVENTUALLY THE TWO PIECES WERE UNSCREWED FROM EACH OTHER. WHEN SPEAKING WITH THE REPORTING PARTY, I ASKED ABOUT THE CERTAINTY OF THE NEEDLE SET BEING CONNECTED TO THE CATHETER UPON INSERTION AND NOT JUST THE STYLET BEING PLACED INTO THE PATIENT'S BODY. THE REPORTING PARTY COULD NOT ANSWER IF THIS WAS THE POSSIBLE OCCURRENCE. THEY REPORTED HAVING BOTH PIECES OF THE NEEDLE SET. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. THE ON SCENE MEDIC SUPERVISOR. REPORTING PARTY STATED THIS WAS A SIDS CASE. RESUSCITATION WOULD NOT HAVE CHANGED THE OUTCOME, EVEN HAD THE INITIAL NEEDLE NOT FAILED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED".

  Patient problems: Insufficient Information

  MAUDE report 19103115 ↗
• MalfunctionNov 16, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT "[THE USER] HAD TWO 15MM EZ-IO NEEDLES FUNCTION INAPPROPRIATELY ON SCENE OF A CALL. THE PATIENT WAS A 2YO IN CARDIAC ARREST PRIOR TO THE ARRIVAL OF EMS, AND WAS NOT ABLE TO BE REVIVED AFTER RESUSCITATIVE EFFORTS. THE PARAMEDIC ON SCENE REPORTED TO HIM THAT THE INITIAL ATTEMPT FOR INTRAOSSEOUS ACCESS RESULTED IN THE INABILITY TO UNSCREW THE STYLET FROM THE HUB. IN A SECOND ATTEMPT, A DIFFERENT 15MM EZ-IO NEEDLE WAS REMOVED FROM PACKAGING WITH THE PARAMEDIC STATING THAT, PRIOR TO ATTEMPT, HE TESTED THE ABILITY OF THE STYLET TO SCREW AND UNSCREW FROM THE HUB. THE PARAMEDIC THEN STATED THAT THE ONCE THE NEEDLE WAS PLACED INTO THE PATIENT, THE STYLET ON THAT NEEDLE WOULD NOT UNSCREW FROM THE HUB, BY HAND OR WITH PLIERS. AN AMR UNIT THEN ARRIVED ON SCENE AND WAS ABLE TO SUCCESSFULLY PLACE AN EZ-IO NEEDLE FROM THEIR SUPPLY. HE ASSURED ME THAT THE PARAMEDIC ON SCENE WAS VERY EXPERIENCED IN EZ-IO, AND WOULD NOT HAVE BENT THE NEEDLE OR REMOVED THE STYLET PRIOR TO ATTEMPT". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THAT THE PATIENT HAD BEEN SICK FOR 2 DAYS WITH FEVER AND A COUGH. UPON EMS'S ARRIVAL ON SCENE, THE PATIENT WAS IN ASYSTOLE WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149358 ↗
• MalfunctionNov 16, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT "[THE USER] HAD TWO 15MM EZ-IO NEEDLES FUNCTION INAPPROPRIATELY ON SCENE OF A CALL. THE PATIENT WAS A 2YO IN CARDIAC ARREST PRIOR TO THE ARRIVAL OF EMS, AND WAS NOT ABLE TO BE REVIVED AFTER RESUSCITATIVE EFFORTS. THE PARAMEDIC ON SCENE REPORTED TO HIM THAT THE INITIAL ATTEMPT FOR INTRAOSSEOUS ACCESS RESULTED IN THE INABILITY TO UNSCREW THE STYLET FROM THE HUB. IN A SECOND ATTEMPT, A DIFFERENT 15MM EZ-IO NEEDLE WAS REMOVED FROM PACKAGING WITH THE PARAMEDIC STATING THAT, PRIOR TO ATTEMPT, HE TESTED THE ABILITY OF THE STYLET TO SCREW AND UNSCREW FROM THE HUB. THE PARAMEDIC THEN STATED THAT THE ONCE THE NEEDLE WAS PLACED INTO THE PATIENT, THE STYLET ON THAT NEEDLE WOULD NOT UNSCREW FROM THE HUB, BY HAND OR WITH PLIERS. AN AMR UNIT THEN ARRIVED ON SCENE AND WAS ABLE TO SUCCESSFULLY PLACE AN EZ-IO NEEDLE FROM THEIR SUPPLY. HE ASSURED ME THAT THE PARAMEDIC ON SCENE WAS VERY EXPERIENCED IN EZ-IO, AND WOULD NOT HAVE BENT THE NEEDLE OR REMOVED THE STYLET PRIOR TO ATTEMPT". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THAT THE PATIENT HAD BEEN SICK FOR 2 DAYS WITH FEVER AND A COUGH. UPON EMS'S ARRIVAL ON SCENE, THE PATIENT WAS IN ASYSTOLE WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149334 ↗

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-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
• 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