Extracorporeal Life Support | ECMO
ECMO Equipment Updates
ELSO is providing information on ECMO equipment pertinent to our community as it relates to access to equipment and equipment issues. We will be updating this page with the latest information as we receive it. Please share any equipment updates that you believe we should share broadly to the ECMO Community at firstname.lastname@example.org.
HLS Set Advanced (disposable in the Cardiohelp System)
On Feb 13, 2023, Getinge initiated a voluntary Medical Device Correction for HLS Set Advanced due to insufficient evidence of packaging sterility. Getinge has not received any reports of complaints or adverse events due to this issue. There are provisions in the letter to allow continued use of this product should there be no alternative product and supply continues to be available through allocation. The FDA designated this a Class II recall. The letter was updated with additional information on June 27. Getinge expects packaging updates to be validated and implemented in late 2023 – H1 2024.
Quadrox-iD Adult, Quadrox-iD Pediatric and other products
On May 19, 2023, Getinge initiated a voluntary Medical Device Removal for Quadrox-iD Adult/Pediatric and other product due to a risk of potentially compromised packaging sterility. Getinge is requesting that customers return product. Unaffected product is expected to be available in late 2023 – H1 2024 once the packaging is redesigned and revalidate. The FDA designated this a Class II recall.
Note: The FDA definition of “recall” includes corrections where product is not being removed from customer locations. A Class II recall is defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Outside the US
The situation varies greatly by region/country. Please contact your local Getinge representative for more information.
At Medtronic, we partner with clinicians, societies, and healthcare systems every day, and we recognize that the recent absence of another manufacturer's oxygenator has presented challenges for some. Through our partnership with MC3, we remain committed to ECMO care and the community and are working to increase production capabilities and expand access to our line of Nautilus ECMO Oxygenators.
Our Nautilus™* ECMO Oxygenator and Nautilus™* Smart ECMO Module are intended to provide long-term extracorporeal circulation for up to 48 hours in adult and pediatric, adolescent patients with acute respiratory failure or acute cardiopulmonary failure.
Medtronic is committed to being your partner in ECMO care. For more information on product availability in your market, please contact your local Medtronic Sales Representative.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.
Risks of ECLS include heart, vessel, or lung damage, hypoxia, anemia, infection, hemorrhage, liver or kidney failure, stroke, and death.
Only clinicians thoroughly trained in extracorporeal life support procedures should use this device.
Nautilus™* Smart ECMO Module and Nautilus are manufactured by MC3, Inc. and exclusively distributed by Medtronic.