Use caution Medical device recall · FDA · Published February 5, 2025

Medtronic Perfusion Systems Aortic Root Cannula: Risk of Stroke from Loose Material

Recalled Medtronic Perfusion Systems Aortic Root Cannula models 11012 AR, 11014 AR, and variants due to potential loose material causing stroke if not identified before use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1306-2025Medical device Medtronic Perfusion Systems ›

Use caution until it’s fixed

Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

Take action

Contact the company

Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088

✎ GovInfoNow plain-language explainer

Medtronic Perfusion Systems is recalling specific aortic root cannula models because loose material in the male luer connector could cause stroke if not detected before use. This is a safety issue for patients undergoing heart surgery. Read more at govinfonow.com/recall/52969-medtronic-perfusion-systems-aortic-root-cannula-risk-of-stroke-from.

Source Summary by GovInfoNow · govinfonow.com/recall/52969-medtronic-perfusion-systems-aortic-root-cannula-risk-of-stroke-from · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1306-2025

Cite this page

“Medtronic Perfusion Systems Aortic Root Cannula: Risk of Stroke from Loose Material.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52969-medtronic-perfusion-systems-aortic-root-cannula-risk-of-stroke-from. Based on FDA recall #Z-1306-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1306-2025%22&limit=1).

The FDA announced on Feb. 5, 2025, that Medtronic Perfusion Systems is recalling aortic root cannulas due to unexpected loose material in the male luer. The agency said the defect could cause stroke if the device is used without detection.

How to tell if you have it

DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012
CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014
MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L
CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L
DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012
CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

The hazard

The FDA said unexpected loose material in the male luer has been identified in the recalled aortic root cannulas. The agency stated that potential harm if not identified and used includes stroke, which can be reversible or irreversible.

Context

GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since 2017-06-22. Other recent recalls of similar products include Medtronic Perfusion Systems EOPA Cannula Recall: Pinhole Leaks Risk Serious Injury (2026-06-24), Medtronic Pediatric Cannula Recall: Loose Blood Material Risk (2026-05-25), and Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall: Incorrect Tubing Assembly (2026-05-12). Other recent recalls of similar products include Bard Peripheral Vascular Recall: Broviac Cutdown Trays with SureCuff Cuff Risk of Sterile Barrier Compromise (2025-12-12), Medline NAMIC Angiographic Control Syringes Recall: Risk of Loose Connection During Use (2026-02-27), and Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus: Risk of Arterial Sheath Tip Separation (2026-07-09).

How to tell if you have this one

Check for model numbers 11012 AR, 11014 AR, 11012L AR, 11014L AR, or 21012 AR, 21014 AR with the specific serial lots listed in the recall notice. These are used in heart surgery procedures.

Brand
Medtronic Perfusion Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify your cannula model and serial lots by checking the product label for model numbers like 11012 AR or 11014 AR, and the specific serial lots listed in the recall.
Contact Manufacturer
Reach out to Medtronic Perfusion Systems directly to confirm if your cannula is affected and to get instructions for replacement or repair.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Feb 5, 2025Firm started the recall
Mar 13, 2025FDA classified it Class I
Mar 19, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52969-medtronic-perfusion-systems-aortic-root-cannula-risk-of-stroke-from">Medtronic Perfusion Systems Aortic Root Cannula: Risk of Stroke from Loose Material (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1306-2025 (February 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1306-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.