🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 11, 2023 Medtronic Navigation Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Navigation, Inc.
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US, PR, TE

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1666-2023

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