Recall Z-1028-2023— Medtronic Perfusion Systems

Name: FDA recall Z-1028-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2022-12-12. It names one FDA 510(k) clearance: K203111. Product: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.. Reason: An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2022-12-12
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K203111 — Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic·cleared 2021-09-16

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

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.

Reason for recall

An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

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