FDA-Device2025-01-29Class II

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Medtronic Perfusion Systems
Hazard

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Sold states
Worldwide - US Nationwide distribution.
Affected count
930 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2025

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