# FDA recall Z-2119-2020

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

## Product

ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700.     2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card;  (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

## 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-2119-2020
- **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-2119-2020

## Citation

> AI Analytics. FDA recall Z-2119-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2119-2020. Source: US FDA. Licensed CC0.

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