Recall Z-1795-2024— Medtronic Perfusion Systems

Name: FDA recall Z-1795-2024
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: K131269. Product: Medtronic DLP Coronary Ostial Cannulae, Model Number 30050. 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

K131269 — DLP CORONARY OSTIAL PERFUSION CANNULAEMedtronic, Inc.·cleared 2013-07-10

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

Medtronic DLP Coronary Ostial Cannulae, Model Number 30050

Reason for recall

Potential for unsealed sterile packing.

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