Medtronic Navigation, Inc.: Device Recall

Recall #Z-0050-2025 · 08/22/2024

Class II: Risk

Recall Details

Recall Number: Z-0050-2025
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic Navigation, Inc.
Status: Ongoing
Date Initiated: 08/22/2024
Location: Lafayette, CO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,801 systems

Reason for Recall

Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.

Product Description

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

Distribution Pattern

Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.

Other Recalls by Medtronic Navigation, Inc.

Class II: Risk 12/04/2024

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

View all recalls by Medtronic Navigation, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.