# FDA recall Z-0508-2020

> **Medtronic Neuromodulation** · Class I · device recall initiated 2019-10-11.

## Product

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

## Reason for recall

There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

## Distribution

US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)

## Key facts

- **Recall number:** Z-0508-2020
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-11
- **Report date:** 2019-12-11
- **Termination date:** 2023-09-15

- **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-0508-2020

## Citation

> AI Analytics. FDA recall Z-0508-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0508-2020. Source: US FDA. Licensed CC0.

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