# FDA recall Z-0509-2026

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2025-10-03.

## Product

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

## Reason for recall

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0509-2026
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-03
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2026

## Citation

> AI Analytics. FDA recall Z-0509-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0509-2026. Source: US FDA. Licensed CC0.

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