Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- Recall date
- October 3, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0289-2025
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Why it was recalled
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
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