Medtronic recalls DLP Aortic Root Cannula with Flow-Guard (REF 11012) due to potential sterility breach from misaligned seal in specific lots. Affected units sold for cardiopulmonary bypass surgery.
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Medtronic is recalling a specific type of surgical cannula used in heart-lung bypass procedures because a seal misalignment could cause a sterility breach. This risk affects only certain lots manufactured in 2023 and 2024.
The cannula's seal may misalign during manufacturing, creating a potential pathway for contamination. This could lead to a sterility breach if the cannula is used in surgery, risking infection in patients.
Surgical teams using the Medtronic DLP Aortic Root Cannula with Flow-Guard (REF 11012) for cardiopulmonary bypass procedures. The risk is highest for hospitals using the specific lots listed in the recall.
Check for the product name 'DLP Aortic Root Cannula with Flow-Guard', reference number REF 11012, and lot numbers 2023050066, 202307C101, or 202401C304. These units were sold for cardiopulmonary bypass surgery.
Look for the lot numbers 2023050066, 202307C101, or 202401C304 on the cannula packaging or label.
The product is safe for use only if it has a lot number not listed in the recall. If your lot number matches the recalled ones, it may have a sterility risk.
Check the lot number on the cannula's packaging or label. Affected lots are 2023050066, 202307C101, or 202401C304.
The recall does not specify a remedy, so contact Medtronic directly to discuss next steps for affected units.
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-0289-2025 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0289-2025 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.
