# FDA recall Z-1408-2023

> **Medtronic Neuromodulation** · Class II · device recall initiated 2023-03-17.

## Product

Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation

## Reason for recall

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side.  As a result, the dual carrier cannot be used to pass two extensions simultaneously.

## Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1408-2023
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-17
- **Report date:** 2023-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2023

## Citation

> AI Analytics. FDA recall Z-1408-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1408-2023. Source: US FDA. Licensed CC0.

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