Recall Z-1306-2025— Medtronic Perfusion Systems

Name: FDA recall Z-1306-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-05

Class I · Ongoing

Class I FDA medical device recall by Medtronic Perfusion Systems, initiated 2025-02-05. It names one FDA 510(k) clearance: K100274. Product: 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. Reason: 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)..

Recalling firm: Medtronic Perfusion Systems
Classification: Class I
Status: Ongoing
Initiated: 2025-02-05
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K100274 — MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014LMedtronic, Inc.·cleared 2010-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.