# FDA recall Z-1995-2020

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2019-08-09.

## Product

Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License  and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure.    Neurological stereotaxic Instrument.

## Reason for recall

Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a  fiducial-less  procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

## Distribution

Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.

## Key facts

- **Recall number:** Z-1995-2020
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-09
- **Report date:** 2020-05-27
- **Termination date:** 2024-04-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2020

## Citation

> AI Analytics. FDA recall Z-1995-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1995-2020. Source: US FDA. Licensed CC0.

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