Class II

Medical Device Recall: Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Medtronic Perfusion Systems · October 3, 2024

Reason for Recall

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Distribution

US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

States Affected

IL, MI, NJ, NY, OH, TN, WI

Quantity Affected

420 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0289-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medtronic Perfusion Systems Medical Device Recall: Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery | SafeCheck