Reported Jun 14, 2023 · Ongoing
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
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. · 200 Medtronic Drive · Lafayette, CO · 80026
Is this the product you have?
- StealthStation Cranial Software
- Model
9735585used with StealthStation S7/i7 systems
- Lot codes and dates
- Model/UDI-DI/Software Versions
9735585/0076300025316500763000306762 (inside
- Kits
0076300029992700763000299972)00763000517267(inside
- Kits
0076300051727400763000517335)/v3.1.13.1.2and 3.1.3
- Model/UDI-DI/Software Versions
- Amount recalled
- 556
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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