Reported May 27, 2020 · Terminated
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS…
Medtronic Navigation, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- 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.
- Lot codes and dates
- 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)
0064316987820400643169625549
- O-Arm Imaging System GTIN(s)
0076300006807300763000068080007630000680970076300006810300763000074050007630000740670076300007407400763000074081007630000740980076300007410400763000074111007630000741280076300007413500763000079000007630000790170076300007902400763000079031007630000790480076300007905500763000079062007630000790790076300007908600763000079093007630000791090076300007921500763000079246007630000792600076300008096900763000080976007630000809830076300008099000763000081003007630000810100076300008102700763000081034007630000810410076300008105800763000081065007630000810720076300008108900763000081096 and 00763000081102
- Nexframe Stereotactic System GTIN(s)
DB-204000643169214811MI-100000643169986763MI-200000643169986770NP-100000613994747877
- Amount recalled
- 61 customers purchased the specified combination of equipment which may lead to this error.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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