Medtronic Navigation, Inc.: StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

Recall number

Z-1630-2023

Recalling firm

Medtronic Navigation, Inc.

Product

StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

Status

Open, Classified

Initiated

2023-04-11

Posted

2023-06-02

Terminated

not on file

Reason

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

Root cause

Software design

Action

On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the following: a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures. In accordance with the IFU: 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. Always use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system. b) 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 neuro.quality@medtronic.com. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update and will communicate additional information when it becomes available. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at rs.navtechsupport@medtronic.com

Quantity

746

Distribution

Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM

Lot, serial or model codes

Model/UDI-DI; Software Version: 9735585/00763000631635, 9735586/00763000631765, 9735587/00763000631826; 3.1.4

510(k) numbers

["K221087"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1000517638

Firm city

Lafayette

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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