Medtronic Navigation, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0188-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

Product Classification:

Class I

Date Initiated: September 27, 2023

Date Posted: November 15, 2023

Recall Number: Z-0188-2024

Event ID: 93158

Reason for Recall:

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

Status: Ongoing

Product Quantity: 5,240 affected systems

Code Information:

Model Number: 9735762 UDI-DI Code: 00763000532123 Software Versions 2.0 and 2.0.1 All systems with the impacted software version regardless of how it was purchased Updated list of Product Models/Serial provide on 06/06/2024 and was uploaded to Associated Documents.

Distribution Pattern:

Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.(foreign) including countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNES, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIAN FEDERATION, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM

Voluntary or Mandated:

Voluntary: Firm initiated