# FDA recall Z-1800-2024

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2024-03-19.

## Product

Medtronic Aortic Root Cannulae and Cardioplegia Needles:    a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009;  b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle   Neonatal   0.64 cm (1/4 in) Tip Length, Model Number 11316;   c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

## Reason for recall

Potential for unsealed sterile packing.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1800-2024
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-19
- **Report date:** 2024-05-22

- **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-1800-2024

## Citation

> AI Analytics. FDA recall Z-1800-2024. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1800-2024. Source: US FDA. Licensed CC0.

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