FDA-Device2024-11-13Class II
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Medtronic Perfusion Systems
Hazard
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Sold states
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Affected count
420 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2025Don't want to check this manually?
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