Home / Recalls / Medtronic Navigation, Inc. / Z-0188-2024

Z-0188-2024 Class I Ongoing

Recalled by Medtronic Navigation, Inc. — Lafayette, CO

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
September 27, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,240 affected systems

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.

Reason for Recall

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

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

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.

Other recalls by Medtronic Navigation, Inc.

  • Z-1022-2025 Class II — Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, (December 4, 2024)
  • Z-0050-2025 Class II — StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stealth (August 22, 2024)
  • Z-1776-2024 Class I — Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used i (March 26, 2024)
  • Z-0699-2024 Class II — Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS (November 28, 2023)
  • Z-0698-2024 Class II — Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS (November 28, 2023)
  • Z-1666-2023 Class I — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 (April 11, 2023)
  • Z-1630-2023 Class I — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), (April 11, 2023)
  • Z-1039-2023 Class II — AxiEM" Non-Invasive Patient Tracker (December 15, 2022)
  • Z-0953-2023 Class II — RadiaLux Lighted Retractor (Pink), REF: 50-101-1 (December 8, 2022)
  • Z-0244-2023 Class II — Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM T (October 14, 2022)