# FDA recall Z-2241-2026

> **Medtronic Neuromodulation** · Class II · device recall initiated 2026-05-13.

## Product

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

## Reason for recall

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

## Distribution

Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-2241-2026
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-13
- **Report date:** 2026-06-03

- **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-2241-2026

## Citation

> MORVS. FDA recall Z-2241-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2241-2026. Source: US FDA. Licensed CC0.

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