StealthStation 9735762Recalls & reported problems
Medtronic Navigation, Inc. · SFW 9735762 APP STEALTH S8 APPLICATION · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Mar 26, 2024Open, Classified
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Z-1776-2024 · Root cause: Software design · Recall details · FDA record ↗
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
- StealthStation Cranial Software 9735762Medtronic Navigation, Inc. · Ear, Nose, and Throat Stereotaxic Instrument1 recall0 reports
- Medtronic Navigation 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
- TruDi NAV Suction TDNS070ZAcclarent, Inc. · Ear, Nose, and Throat Stereotaxic Instrument25 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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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