# FDA recall Z-0614-2024

> **Medtronic Neuromodulation** · Class II · device recall initiated 2023-11-13.

## Product

Medtronic SynchroMed II, Model 8637-20, Programmable pump

## Reason for recall

Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0614-2024
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-13
- **Report date:** 2024-01-03

- **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-0614-2024

## Citation

> AI Analytics. FDA recall Z-0614-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0614-2024. Source: US FDA. Licensed CC0.

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