Reported Jun 14, 2023 · Ongoing
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), 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
- Models
97355859735586 (kit)9735587 (kit)used with StealthStation S7/i7 systems
- Lot codes and dates
- Model/UDI-DI
- Software Version
9735585/007630006316359735586/007630006317659735587/007630006318263.1.4
- Amount recalled
- 746
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
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
Using this product could cause serious injury, illness or death — stop using it now.
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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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