# FDA recall Z-2121-2020

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

## Product

LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500.   Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.    Package Contents  Percutaneous Permanent Lead Kits  (1) Percutaneous Lead with pre-loaded Curved Stylet  (1) Stylet Ring with a Curved and a Straight Stylet  (4) Suture Sleeves  (1) Insertion Needle with Stylet  (1) Lead Blank  (1) Steering Cap  (1) OR Cable Assembly  (2) Lead Position Labels left and right (non-sterile)  (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-2121-2020
- **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-2121-2020

## Citation

> AI Analytics. FDA recall Z-2121-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2121-2020. Source: US FDA. Licensed CC0.

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