EVERESTRecalls & reported problems across all models

We found 6 models of EVEREST by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Aug 26, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EVEREST problems

EVEREST models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVEREST™ AC3200

  Syringe, balloon inflation
  7 reports
• EVEREST™ AC3200

  Syringe, balloon inflation
  5 reports
• EVEREST™ AC2200

  Syringe, balloon inflation
  3 reports
• EVEREST™ AC2205P

  Syringe, balloon inflation
  3 reports
• EVEREST™ AC3200

  Syringe, balloon inflation
  2 reports
• EVEREST™ AC3200

  Syringe, balloon inflation
  1 report

Recent EVEREST adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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