# FDA recall Z-2811-2026

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2026-06-24.

## Product

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

## Reason for recall

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2811-2026
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-24
- **Report date:** 2026-08-05

- **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-2811-2026

## Citation

> AI Analytics. FDA recall Z-2811-2026. Retrieved 2026-08-31 from https://api.ai-analytics.org/recall/Z-2811-2026. Source: US FDA. Licensed CC0.

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