EVEREST™ AC2205PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169843028), received between Jun 2, 2022 and Jul 11, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE. IT WAS REPORTED THAT A MANOMETER ISSUE OCCURRED AND THERE WAS A PROBLEM WITH THE INFLATION DEVICE. IT WAS STATED THAT WHEN PASSING MORE THAN ONE GUIDE WIRE, THERE WAS DIFFICULTY WITH OCCLUSION OF THE DEVICE, WHICH RESULTED IN EXCESS BLOOD LOSS, AS WELL AS INJECTED CONTRAST. THERE WAS CONCERNS THAT THIS HIGHER-THAN-EXPECTED BLOOD LOSS COULD HARM THE PATIENT'S RECOVERY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19718306 ↗
• MalfunctionJan 26, 2024Display or Visual Feedback Problem; Inflation Problem; Use of Device Problem; Display or Visual Feedback Problem; Inflation Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE ALLEGED ISSUE DID NOT OCCUR DURING PREP. IT WAS REPORTED THAT THERE WAS A MANOMETER ISSUE. THE NEEDLE WAS UNRESPONSIVE DURING USE, AND DURING BALLOON INFLATION. THE DEVICE WAS CONNECTED TO A STENT WHICH WAS INSIDE THE PATIENT WHEN THE ISSUE OCCURRED. THE EVEREST DEVICE WAS EXPIRED AT THE TIME OF USE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585844 ↗
• MalfunctionJun 2, 2022Display or Visual Feedback Problem; Defective Device; Display or Visual Feedback Problem; Defective Device

  ONE EVEREST SURVIVAL KIT WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS CONNECTED TO A STENT DEVICE WHICH WAS INSIDE THE PATIENT. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MANOMETER. THE MANOMETER WAS DAMAGED AND NO PRESSURE DISPLAYED DURING INFLATION. IT WAS ALSO REPORTED THAT THE STENT COULD NOT BE INFLATED OR FULLY OPEN AS NO PRESSURE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THE SAME TYPE OF STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572517 ↗