FDAMarch 19, 2024device

Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for unsealed sterile packing.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic perfusion systemsmedtronicmedtronic perfusion

UPCs

00673978178646206139944954202061399467614020613994495499

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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