EVEREST™ AC3200 (UDI 00763000338190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000338190), received between Jan 16, 2023 and Aug 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONE EVEREST INFLATION DEVICE WAS NOT WORKING PROPERLY DURING A PROCEDURE. THE DEVICE EXPERIENCED INFLATION DIFFICULTIES IN THE PATIENT AND WAS NOT ABLE TO INFLATE AND DEFLATE PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897429 ↗
• MalfunctionMar 25, 2024Deflation Problem; Display or Visual Feedback Problem; Leak/Splash; Material Deformation; Deflation Problem; Display or Visual Feedback Problem; Leak/Splash; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE ALLEGED ISSUES OCCURRED DURING PREP, AND WHEN THE EVEREST WAS CONNECTED TO A MATING DEVICE INSIDE THE PATIENT. IT WAS REPORTED THAT THERE WAS A MANOMETER ISSUE, AND THE MANOMETER WAS DAMAGED. IT WAS DETAILED THAT DURING PREP THE MANOMETER DID NOT GIVE PROPER PRESSURE. IT WAS THAN ATTEMPTED TO DEFLATE THE BALLOON IN THE PATIENT BUT THE BALLOON DID NOT DEFLATE COMPLETELY. THE ISSUE WAS NOTICED DURING A PROCEDURE IN THE PATIENT. THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967198 ↗
• MalfunctionMar 20, 2024Display or Visual Feedback Problem; Inflation Problem; Display or Visual Feedback Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE DURING A PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE CATH LAB FOR EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI). THE EVEREST DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. DURING THE OPERATION THE EVEREST INFLATION DEVICE WAS BEING USED FOR BALLOON DILATION. THE DEVICE WAS DIRECTLY CONNECTED TO A MEDTRONIC BALLOON. IT WAS REPORTED THAT AFTER MULTIPLE ATTEMPTS THE INFLATION PRESSURE COULD NOT BE REACHED. THERE WAS A DISPLAY ISSUE NOTED. WHEN ROTATING AND PRESSURIZING, THE PRESSURE PUMP POINTER DID NOT CHANGE. THE NEEDLE DID NOT MOVE AT ALL WHEN PRESSURE WAS APPLIED. THE DEVICE THAT WAS CONNECTED TO THE EVEREST WAS BEING USED IN THE PATIENT WHEN THE ISSUE OCCURRED. A BALLOON BURST DID NOT OCCUR BECAUSE OF THE EVENT. A NEW INFLATION DEVICE WAS REQUESTED, AND THE OPERATION CONTINUED SUCCESSFULLY WITHOUT CAUSING ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT RETURNED TO THE WARD AFTER THE OPERATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938895 ↗
• MalfunctionDec 15, 2023Deflation Problem; Display or Visual Feedback Problem; Inflation Problem; Deflation Problem; Display or Visual Feedback Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE ALLEGED ISSUE DID NOT OCCUR DURING PREP. IT WAS REPORTED THAT INFLATION AND DEFLATION DIFFICULTIES OCCURRED IN THE PATIENT. THERE WAS AN INABILITY TO INFLATE OR DEFLATE. THE EVEREST DEVICE WAS CONNECTED TO A STENT WHEN THE ISSUE OCCURRED. THERE WAS NO STOPCOCK ATTACHED. THE ISSUE WAS NOTED AFTER CONNECTING TO THE STENT AND PULLING THE INFLATION DEVICE HANDLE BACK TO GO TO THE NEGATIVE POSITION, THEN RELEASING FROM NEGATIVE TO INFLATE THE STENT. THE DEVICE HANDLE WAS TURNED BUT THERE WAS NO INFLATION, AND THEN SUDDENLY THE PRESSURE NEEDLE MOVES QUICKLY TO READ A HIGH PRESSURE BUT YET THE STENT BALLOON WAS NOT INFLATED AT ANY TIME. THE EVEREST WAS DISCONNECTED FROM THE STENT, WITH NO ISSUE NOTED AS REGARDS THE STENT. THE DEVICE HAD BEEN USED PREVIOUSLY DURING THE CASE TO INFLATE A BALLOON WITH NO ISSUE. A NEW EVEREST INFLATION DEVICE WAS OPENED AND USED WITH NO FURTHER ISSUE NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333572 ↗
• MalfunctionSep 1, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  AN ATTEMPT WAS MADE TO USE ONE AC3200 EVEREST INFLATION DEVICE DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MANOMETER. IT WAS DETAILED THAT WHEN THE BALLOON WAS INFLATED DURING THE OPERATION THE PRESSURE PUMP DID NOT INCREASE IN PRESSURE. THE NEEDLE WAS UNRESPONSIVE DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669164 ↗
• MalfunctionJul 28, 2023Display or Visual Feedback Problem; Inflation Problem; Display or Visual Feedback Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE DURING AN ANGIOGRAPHIC STENTING PROCEDURE. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED. IT WAS DETAILED THAT THE INFLATION DEVICE WAS WORKING CORRECTLY ON STENT DEPLOYMENT, HOWEVER WHEN THE EVEREST DEVICE WAS BEING USED FOR POST DILATION IT DID NOT GO DOWN TO 0 ATM PRESSURE. THE EVEREST DEVICE WAS REPLACED WITH A NEW DEVICE WHICH FUNCTIONED AS INTENDED TO INFLATE THE BALLOON. POST PROCEDURE THE ISSUE WAS REPLICATED WITH JUST AIR. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412219 ↗
• MalfunctionJan 16, 2023Corroded; Display or Visual Feedback Problem; Inflation Problem; Material Deformation; Corroded; Display or Visual Feedback Problem; Inflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EVEREST INFLATION DEVICE. ON PHYSICAL OBSERVATION THERE WAS NO DEFECT ON THE MANOMETER. IT WAS REPORTED THAT WHEN ATTEMPTS WERE MADE TO INFLATE THE INDEFLATOR, THE PRESSURE CHANGED FROM 2 ATM TO 6 ATM. THERE WERE A FEW ATTEMPTS TO INFLATE THE INDEFLATOR, BUT THE SAME ISSUE HAPPENED ON EACH ATTEMPT. THE INFLATION PRESSURE NEVER PROCEEDED TO MORE THAN 6 ATM. THE PRESSURE NEEDLE RETURNED BACK TO ZERO WHEN PRESSURE WAS RELEASED. THE DEVICE THAT WAS CONNECTED TO THE EVEREST WAS BEING USED IN THE PATIENT WHEN THE ISSUE OCCURRED. THERE WAS NO BALLOON BURST AS A RESULT OF THIS EVENT AS THE PRESSURE NEVER WENT ABOVE 6 ATM. THE DEVICE WAS CHANGED TO A NEW INDEFLATOR WITH NO ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173285 ↗