EVEREST™ AC3200 (UDI 00643169014800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169014800), received between Apr 27, 2017 and Apr 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K960983); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2017Unable to Obtain Readings; Unable to Obtain Readings

  THE PHYSICIAN INTENDED TO USE AN EVEREST INFLATION DEVICE. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU, INSPECTED AND PREPPED; NO DEFECTS NOTED. IT IS REPORTED THAT DURING USE WHEN PRESSURE WAS APPLIED TO THE DEVICE, THE NEEDLE DID NOT MOVE. INFLATION DEVICE WAS ATTACHED TO THE NON MDT BALLOON HUB AND INSERTED INTO THE PATIENT VESSEL. THE NURSE APPLIED PRESSURE TO THE INFLATION DEVICE THAT WAS PREPARED AS PER INSTRUCTIONS FOR USE. AS THE NURSE WAS TURNING THE HANDLE, THE PRESSURE NEEDLE ON THE GAUGE REMAINED AT ZERO. IT DID NOT REGISTER PRESSURE. AN X-RAY IMAGE WAS TAKEN AND THE BALLOON HAD BURST. HOWEVER, THE VESSEL DIDN'T RUPTURE OR DISSECT. A NEW AC3200 AND BALLOON WERE USED. THE BALLOON WAS ABLE TO BE INFLATED AND THE CASE COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960983. One submission often covers many models, so check the product and lot details in each record.

• Z-2271-2010 · Jul 16, 2010 · Terminated
  Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
• Z-2272-2010 · Jul 16, 2010 · Terminated
  Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
• Z-2273-2010 · Jul 16, 2010 · Terminated
  Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.