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StealthStation S8
MEDTRONIC NAVIGATION, INC. · Model 9735920 · UDI-DI 00763000769017
1
510(k) clearances
1,712
Adverse events (1 deaths)
17
Recalls
44
Facilities
Description
SW KIT 9735920 S8 2.1 ENT PLAN STATION
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-03 | Integra LifeSciences Corp. (NeuroSciences) | It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may |
| 2024-07-09 | Integra LifeSciences Corp. | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actu |
| 2024-04-04 | Stryker Leibinger GmbH & Co. KG | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer o |
| 2023-09-21 | Acclarent, Inc. | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during su |
| 2021-11-12 | Acclarent, Inc. | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the sur |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2019-03-06 | Acclarent, Inc. | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| 2017-06-29 | Medtronic Navigation, Inc. | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| 2017-06-29 | Medtronic Navigation, Inc. | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.