FDA Device recall Z-1995-2020
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthS…
- FDA Device
- Class I
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class I recall of Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthS… by Medtronic Navigation, citing entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic Syste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1995-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-08-09 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
Reason
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Identifiers
| code_info | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS…Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS procedure. Stealthware Station Cranial Software GTIN(s): 00643169878204, 00643169625549 O-Arm Imaging System GTIN(s): 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2020%22
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