Recall Z-0289-2025— Medtronic Perfusion Systems

Name: FDA recall Z-0289-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-03

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-10-03. It names one FDA 510(k) clearance: K790565. Product: Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery. Reason: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal.

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-10-03
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K790565 — AORTIC ROOT CANNULADlp, Inc.·cleared 1979-06-11

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 Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Reason for recall

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

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