# FDA recall Z-2124-2020

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

## Product

Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage:   Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted.  Package Contents:  Lead Extension Kit  (1) Lead Extension  (1) Hex Wrench  (1) Tunneling Tool Assembly  (1) Device Registration Form/Temporary Patient Identification Card  (1) Manual

## 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-2124-2020
- **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-2124-2020

## Citation

> AI Analytics. FDA recall Z-2124-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2124-2020. Source: US FDA. Licensed CC0.

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