Recall Z-1800-2024— Medtronic Perfusion Systems

Name: FDA recall Z-1800-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-19

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-03-19. It names one FDA 510(k) clearance: K182586. Product: 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. Reason: Potential for unsealed sterile packing..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-03-19
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K182586 — DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure PortMedtronic, Inc.·cleared 2018-10-19

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

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

Reason for recall

Potential for unsealed sterile packing.

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