# FDA recall Z-0289-2025

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2024-10-03.

## Product

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

## Reason for recall

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

## Distribution

US:  NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

## Key facts

- **Recall number:** Z-0289-2025
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-03
- **Report date:** 2024-11-13

- **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-0289-2025

## Citation

> AI Analytics. FDA recall Z-0289-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0289-2025. Source: US FDA. Licensed CC0.

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