EVEREST™ AC3200 (UDI 00643169621916)Recalls & reported problems
Medtronic, Inc. · INFLATION DEV AC3200 EVEREST 30 TJM · Class 2
All models of EVEREST (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169621916), received between Oct 20, 2017 and Apr 5, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper Device Output” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper Device Output1
- Unable to Obtain Readings1
Patient problems
- No Consequences Or Impact To Patient2
- Patient Problem/Medical Problem1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2018Improper Device Output; Improper Device Output
THE PHYSICIAN INTENDED TO USE AN EVEREST INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE ALLEGED ISSUE OCCURRED WHEN THE INDEFLATOR WAS CONNECTED TO A BALLOON CATHETER, WHICH WAS BEING USED IN A PATIENT. A STOPCOCK WAS ALSO CONNECTED BETWEEN THE EVEREST AND THE BALLOON CATHETER. IT IS REPORTED THAT THERE WAS A LOT OF RESISTANCE FELT WHILE TURNING THE KNOB DURING INFLATION, AND THE BALLOON FAILED TO INFLATE. IT IS ALSO REPORTED THAT THE DIAL DID NOT MOVE WHEN THE HANDLE WAS TURNED. NO PATIENT INJURY IS REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER INDEFLATOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7398930 ↗InjuryOct 20, 2017Unable to Obtain Readings; Unable to Obtain Readings
THE PHYSICIAN INTENDED TO USE AN EVEREST INFLATION DEVICE TO TREAT A LESION IN THE DIAGONAL BRANCH WITH 60% STENOSIS. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU. THE DEVICE WAS CONNECTED TO A BALLOON CATHETER. IT IS REPORTED THAT NO SIGNAL OF INCREASING PRESSURE DISPLAYED ON THE DEVICE AND THE BALLOON BURST IN THE ARTERY. NO PATIENT INJURY IS REPORTED.
Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem; Perforation
MAUDE report 6964690 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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