EVEREST™ AC3200 (UDI 00643169843035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169843035), received between Nov 16, 2021 and Jun 16, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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.

• MalfunctionJun 16, 2022Display or Visual Feedback Problem; Defective Device; Physical Resistance/Sticking; Display or Visual Feedback Problem; Defective Device; Physical Resistance/Sticking

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED. THE ISSUE DID NOT OCCUR DURING PREP. IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE HOWEVER DURING USE OF THE DEVICE IN THE PATIENT, IT WAS DETAILED THAT THE DEVICE WAS STUCK AT LEVEL 8 AND MANIPULATION DIFFICULTIES WERE ENCOUNTERED. THE IN-DEFLATOR WAS NOT CONNECTED TO A MATING DEVICE WHEN THE ISSUE OCCURRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712920 ↗
• MalfunctionJun 16, 2022Display or Visual Feedback Problem; Inflation Problem; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Inflation Problem; Device Difficult to Setup or Prepare

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO EVEREST INFLATION DEVICES. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED. THE ISSUE DID NOT OCCUR DURING PREP. DURING USE IN THE PATIENT, IT WAS DETAILED THAT THE DEVICES WERE STUCK AT LEVEL 8 IN THE CHAMBER WITH MANIPULATION DIFFICULTIES ENCOUNTERED. THE IN-DEFLATOR WAS NOT CONNECTED TO A MATING DEVICE WHEN THE ISSUE OCCURRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712622 ↗
• MalfunctionJun 16, 2022Display or Visual Feedback Problem; Inflation Problem; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Inflation Problem; Device Difficult to Setup or Prepare

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO EVEREST INFLATION DEVICES. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED. THE ISSUE DID NOT OCCUR DURING PREP. DURING USE IN THE PATIENT, IT WAS DETAILED THAT THE DEVICES WERE STUCK AT LEVEL 8 IN THE CHAMBER WITH MANIPULATION DIFFICULTIES ENCOUNTERED. THE IN-DEFLATOR WAS NOT CONNECTED TO A MATING DEVICE WHEN THE ISSUE OCCURRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712509 ↗
• MalfunctionJan 31, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ONE EVEREST INFLATION DEVICE WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 60% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 INSPECTED AND PREPPED PER IFU, WITH NO ISSUES NOTED. IT WAS REPORTED THAT WHEN THE DEVICE WAS CONNECTED TO A BALLOON IN THE PATIENT, THE INFLATION DEVICE WAS FOUND TO BE DEFECTIVE AND THE PRESSURE DID NOT RETURN UP AND DOWN ON THE GAUGE. IT WAS STATED THAT 6 ATM PRESSURE HAD BEEN APPLIED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392027 ↗
• MalfunctionNov 16, 2021Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818610 ↗