Home / Recalls / Medtronic Navigation, Inc. / Z-1776-2024

Z-1776-2024 Class I Ongoing

Recalled by Medtronic Navigation, Inc. — Lafayette, CO

Recall Details

Product Type
Devices
Report Date
May 15, 2024
Initiation Date
March 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3286 applications.

Product Description

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Reason for Recall

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Code Information

UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

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-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-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)