EVEREST™ AC2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169843011), received between Sep 8, 2022 and Oct 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionOct 26, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NO VISUAL DAMAGE WAS NOTED TO THE IN-DEFLATOR. IT WAS REPORTED THAT AN ISSUE OCCURRED WITH THE MANOMETER AND THAT IT WAS DAMAGED. IT WAS STATED THAT THE VALVE WAS LEAKING AND PRESSURE COULD NOT BE HELD OR BUILT UP. THE LEAK WAS NOTED AFTER THE DEVICE WAS CONNECTED TO A PCI BALLOON, NEGATIVE PRESSURE APPLIED AND ADVANCED INTO THE LESION AND WAS BEING USED IN THE PATIENT WHEN THE ISSUE OCCURRED. THE ISSUE WAS ALSO IDENTIFIED DURING PREP WHEN THE IN-DEFLATOR WAS NOT CONNECTED TO A MATING DEVICE. THE DEVICE WAS STILL USED IN THE PATIENT. THE PCI BALLOON WAS CHECKED FOR LEAKAGE AFTER REMOVAL AND THIS WAS NOT THE CASE. A CHECK OF THE INFLATOR VISUALLY AND AFTER DISCONNECTION OF THE 3-WAY STOPCOCK WAS DONE. CONTROL OF THE APPLICATION BY ATTEMPTED PRESSURE BUILD-UP OUTSIDE THE PATIENT WAS ATTEMPTED. PRESSURE BUILD-UP WAS NOT POSSIBLE. IMMEDIATE PRESSURE DROP, DESPITE MANUAL PRESSURE INCREASE VIA ROTATION. VISUALLY CONTINUOUS PRESSURE LOSS VISIBLE VIA THE MANOMETER. IT IS BELIEVED THAT THE LEAK MAY HAVE OCCURRED AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672474 ↗
• MalfunctionSep 30, 2022Display or Visual Feedback Problem; Defective Device; Display or Visual Feedback Problem; Defective Device

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED PER THE IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THERE WAS A MANOMETER ISSUE. IT WAS DETAILED THAT THE NEEDLE JUMPED SUDDENLY DURING INFLATION. THE ISSUE OCCURRED DURING BALLOON INFLATION WHILE PRESSURE WAS APPLIED. INITIALLY THE NEEDLE DIDN'T REACT, HOWEVER, AFTERWARDS IT JUMPED FROM 0 TO 12/14 ATM. THE READING RETURNED TO 0 ATM WHEN NEGATIVE PRESSURE WAS DRAWN AND THE BALLOON DEFLATED. A STOPCOCK WAS NOT CONNECTED BETWEEN EVEREST AND BALLOON. THE BALLOON WAS BEING USED IN THE PATIENT WHEN THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SAME BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519248 ↗
• MalfunctionSep 8, 2022Defective Device; Defective Device

  ONE EVEREST INFLATION DEVICE WAS ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE IN-DEFLATOR WAS CONNECTED TO A BALLOON AND STENT DEVICE WHEN THE ISSUE OCCURRED. THERE WAS NO STOPCOCK CONNECTED BETWEEN THE EVEREST AND THE OTHER DEVICES. IT WAS REPORTED THAT A MANOMETER ISSUE OCCURRED. AT FIRST THE NEEDLE WAS UNRESPONSIVE AT 0 ATM AND DIDN'T REACT. AS THE NEEDLE OF THE MANOMETER DID NOT REACT, IT WAS NOT POSSIBLE TO SEE THE GIVEN PRESSURE. THE NEEDLE OF THE MANOMETER THEN JUMPED UP TO 12-14 ATM. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS SUBSEQUENTLY REPORTED THAT THE EVENT OCCURRED DURING USE IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE REPORTED EVEREST DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379758 ↗