# FDA recall Z-0217-2024

> **Medtronic Neuromodulation** · Class II · device recall initiated 2022-05-27.

## Product

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

## Reason for recall

There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

## Distribution

US:  MO, FL, TX, WA

## Key facts

- **Recall number:** Z-0217-2024
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-05-27
- **Report date:** 2023-11-08

- **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-0217-2024

## Citation

> AI Analytics. FDA recall Z-0217-2024. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0217-2024. Source: US FDA. Licensed CC0.

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