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.
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).
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.
The aortic root cannula has a male luer connector that may contain unexpected loose material. If this material is not identified before use, it could lead to stroke during surgery. The risk is only present if the cannula is used without proper inspection.
Patients using these cannulas during heart surgery are most at risk. The recall applies to specific model numbers and serial lots produced between 2022 and 2024.
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.
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.
Reach out to Medtronic Perfusion Systems directly to confirm if your cannula is affected and to get instructions for replacement or repair.
Recalled models include DLP Aortic Root Cannula 11012 AR FLOWGUARD 12GA, 11014 AR FLOWGUARD 14GA, MiAR Cannula 11012L AR FLOWGUARD LONG 12GA, and variants with specific serial lots listed in the recall notice.
Yes, if the loose material is not identified before use, it could cause stroke during surgery. The recall is for patients using these cannulas in heart procedures.
Check the model number and serial lots on your cannula. Affected units have model numbers like 11012 AR, 11014 AR, or 21012 AR with specific serial lots listed in the recall notice.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1306-2025 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1306-2025 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
