Recall Z-1995-2020— Medtronic Navigation, Inc.
Class I · Terminated
Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2019-08-09, terminated 2024-04-02. It names 2 FDA 510(k) clearances: K162309, K153660. 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)..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-08-09
- Terminated
- 2024-04-02
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
2 on FDA's record- K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software
- K153660 — StealthStation System with Cranial Software
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.