StealthStation Cranial recallZ-1666-2023 · Medtronic Navigation, Inc. · initiated Apr 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Software design
What the company is doing
On 4/11/23, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system." 2) All physician users should review the correction notice. Pass on the notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 3) Complete and return the customer confirmation form that can be returned to [email protected]. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at [email protected]
Recall details
- Recall number
- Z-1666-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2023
- Posted by the FDA
- Jun 2, 2023
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 556
- Product code
- HAW
- FDA submissions
- K150216, K190672, K221087, K153660
- Distribution
- 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
Product description
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Code information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- StealthStation® Cranial 9735585Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
8 devices cleared under K150216, K190672, K221087, K153660 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- StealthStation® Cranial 9735585Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall2 reports
- StealthStation® Cranial 9735586Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735585Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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