# FDA recall Z-1776-2024

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2024-03-26.

## Product

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

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.

## Key facts

- **Recall number:** Z-1776-2024
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-26
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lafayette, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2024

## Citation

> AI Analytics. FDA recall Z-1776-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1776-2024. Source: US FDA. Licensed CC0.

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