---
title: "Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... — FDA record Z-0289-2025 | Is It on Recall"
description: "There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal"
url: https://isitonrecall.com/recall/fda-device-z-0289-2025-medtronic-dlp-aortic-root-cannula-with-flow-guard-ref-11012-for-use-in-cardiopulmonary-bypass-surger/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery — FDA record Z-0289-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- **Reason**: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- **Classification**: Class II
- **Recalling firm**: Medtronic Perfusion Systems
- **Quantity**: 420 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0289-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0289-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Illinois](https://isitonrecall.com/state/illinois/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Nov 13, 2024
- **Recall initiation date**: Oct 3, 2024
- **Center classification date**: Nov 4, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0289-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Perfusion Systems records](https://isitonrecall.com/brand/medtronic-perfusion-systems/)