N/A (REF 408310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10841898120275), received between Apr 16, 2019 and Aug 12, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224997 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142807 ↗
• MalfunctionJul 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105015 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER INSERTING THE SHEATH, PULLED OUT THE DILATOR, AND THE HEMOSTASIS VALVE STARTED LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073739 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak; Material Puncture/Hole

  ON (B)(6) 2026, IT WAS REPORTED THAT THE DEVICE HAD TO BE EXCHANGED DUE TO A FAULTY BLEEDBACK VALVE. UPON RECEIPT OF THE DEVICE, THERE WAS A SMALL CUT ON THE HEMOSTASIS TUBING NEAR THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839822 ↗
• MalfunctionJan 20, 2026Leak/Splash

  THE DEVICE WAS REPORTED TO HAVE A LEAKY VALVE AND AIR POSSIBLY ENTERED THE PATIENT. AFTER GOING TRANSSEPTAL, THE NEEDLE AND DILATOR WERE PULLED OUT. WHEN PHYSICIAN WENT TO FLUSH, HE WITHDREW BLOOD AND SAW 10 ML OF AIR. THE PATIENT WAS INITIALLY REPORTED TO HAVE A TRANSIENT ISCHEMIC ATTACK (TIA). ADDITIONAL CLARIFYING INFORMATION WAS PROVIDED BY THE FACILITY THAT THERE WAS THE CONCERN OF A TIA, HOWEVER, THIS WAS RULED OUT AFTER IMAGING WAS COMPLETED.

  Patient problems: Confusion/ Disorientation; Non specific EKG/ECG Changes

  MAUDE report 24118439 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS A DEVICE THAT HAD A LEAKY STOPCOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663902 ↗
• MalfunctionNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS REPORTED TO HAVE VALVE LEAKAGE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170145 ↗
• MalfunctionOct 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS DEVICE WAS REPORTED TO HAVE BLOOD FLOWING OUT FROM THE BLEED-BACK VALVE AT THE END OF THE HANDLE UPON INSERTION OF THE DEVICE. NO INJURIES WERE REPORTED. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981060 ↗
• MalfunctionMay 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS DEVICE WAS REPORTED TO HAVE A ONE-WAY VALVE AND HUB FOUND TO BE FAULTY DURING A PROCEDURE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988675 ↗
• MalfunctionMar 25, 2022Air/Gas in Device; Air/Gas in Device

  THE SIDEPORT OF THIS DEVICE WAS REPORTED TO HAVE AIR BUBBLES MIDWAY THROUGH THE PROCEDURE WHILE CONNECTED TO A TRANSDUCER. THE TIP OF THIS DEVICE WAS IN THE LEFT ATRIUM WHEN THE PHYSICIAN FLUSHED THE SHEATH, RESULTING IN AIR BUBBLES BEING NOTICED AGAIN AFTER A FEW MINUTES. IT WAS AT THIS TIME THAT CONTINUOUS FLUSH WAS CONNECTED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906136 ↗
• InjuryApr 16, 2019Break

  IT WAS REPORTED THAT THE REPROCESSED AGILIS NXT STEERABLE INTRODUCER BROKE DURING AN ABLATION AND PATIENT DEVELOPED CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade

  MAUDE report 8520390 ↗