# FDA recall Z-2125-2020

> **Boston Scientific Neuromodulation Corporation** · Class II · device recall initiated 2019-04-24.

## Product

Fifty-five (55) cm 8 Contact Extension Kit, part number  M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.

## Reason for recall

The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the  "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

## Distribution

Distributed OUS only. to 14 countries.

## Key facts

- **Recall number:** Z-2125-2020
- **Recalling firm:** Boston Scientific Neuromodulation Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-24
- **Report date:** 2020-06-03
- **Termination date:** 2022-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2125-2020

## Citation

> AI Analytics. FDA recall Z-2125-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2125-2020. Source: US FDA. Licensed CC0.

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