AxiEM™ 9735016Recalls & reported problems
Medtronic Navigation, Inc. · SUCTION 9735016 MALLEABLE STD TIP 9-FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000588403), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024
MALLEABLE SUCTION WOULDN'T REGISTER WITH MEDTRONIC STEALTH MACHINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20673920 ↗
Other Ear, Nose, and Throat Stereotaxic Instrument devices
- TruDi NAV Suction TDNS000ZAcclarent, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall61 reports
- Scopis 8000-021-002Stryker Leibinger GmbH & Co. KG · Ear, Nose, and Throat Stereotaxic Instrument1 recall19 reports
- FUSION Compact ™ 9735602Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument64 reports
- TruDi™ Navigation System 1Biosense Webster (Israel) Ltd. · Ear, Nose, and Throat Stereotaxic Instrument1 recall14 reports
- Medtronic Navigation 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- StealthStation Cranial Software 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- StealthStation 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- Scopis ENT 8000-020-002Stryker Leibinger GmbH & Co. KG · Ear, Nose, and Throat Stereotaxic Instrument33 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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