N/A (REF G408324)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841898120282), received between Jun 2, 2023 and Apr 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Fluid/Blood Leak; Material Puncture/Hole

  ON (B)(6) 2026, IT WAS REPORTED THAT AN AGILIS FLUSHED FINE OUT OF THE PACKAGE. WHEN IT WAS INTRODUCED TO THE BODY, THE PHYSICIAN TRIED TO FLUSH BUT FLUID WAS COMING OUT OF THE SIDE PORT INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852101 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Material Puncture/Hole

  ON 2-MAR-2026, IT WAS REPORTED THAT THE PLASTIC TUBING CONNECTED TO THE HUB OF THE SHEATH HAD A HOLE AND WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690861 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak; Mechanical Problem; Gas/Air Leak

  THE DEVICE WAS REPORTED TO HAVE LEAKING OUT OF THE SHEATH ONCE IT WAS PLACED INTO THE BODY. THE MANEUVERABILITY OF THE SHEATH WAS REPORTED TO BE UNACCEPTABLE, AND THERE WERE BUBBLES REPORTED TO BE IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476368 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  THE DEVICE WAS REPORTED TO HAVE BLOOD LEAKING OUT OF THE HEMOSTASIS TUBING/HEMOSTASIS HUB JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381534 ↗
• MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS DEVICE WAS REPORTED TO HAVE A BLEED-BACK VALVE THAT WOULD NOT HOLD PRESSURE. BLOOD WAS REPORTED TO BE FLOWING OUT OF THE END OF THE AGILIS DEVICE UNTIL ANOTHER CATHETER WAS RE-INSERTED. NO INJURIES WERE REPORTED. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051772 ↗