Home / Recalls / Medtronic Navigation, Inc. / Z-1666-2023

Z-1666-2023 Class I Ongoing

Recalled by Medtronic Navigation, Inc. — Lafayette, CO

FDA device recall Z-1666-2023 was initiated by Medtronic Navigation, Inc. on April 11, 2023 and is designated Class I. Reason for recall: 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 placemen… The recall status is ongoing. Affected quantity: 556.

Recall Details

Product Type
Devices
Report Date
June 14, 2023
Initiation Date
April 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
556

Product Description

StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

Reason for Recall

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

Distribution Pattern

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

Code Information

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

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-0188-2024 Class I — StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Stealt (September 27, 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)

FDA data resources