CLASS I ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report
StealthStation Cranial recalled by Medtronic Navigation
Medtronic Navigation is recalling StealthStation Cranial, distributed in Puerto Rico. The recall was initiated on 11 Apr 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1666-2023
- FDA event ID
- 92269
- Recalling firm
- Medtronic Navigation, Lafayette, CO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Apr 2023
- FDA classified
- 2 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Medical Software
Timeline
| 11 Apr 2023 | Recall initiated by company | |
| 2 Jun 2023 | Classified by FDA | +52 days |
| 14 Jun 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Where it was distributed
US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES
Stores named: Target
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3
Where was it sold?
US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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