Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic DLP Aortic Root Cannula with Flow-Guard Recalled by Medtronic Perfusion Systems Due to There is the potential for a potential sterility...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.
Affected Products
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Quantity: 420 units
Why Was This Recalled?
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Where Was This Sold?
This product was distributed to 7 states: IL, MI, NJ, NY, OH, TN, WI
About Medtronic Perfusion Systems
Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report