Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR…

Recall date

February 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1306-2025

FDA classification

Class I

Brand / firm

Medtronic Perfusion Systems

Sold / distributed

Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa…

Why it was recalled

Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014