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 support@elso.org.
FDA – US
Cardiohelp and HLS Sets
On May 8, 2024 the FDA released the following statement: Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to Health Care Providers.
ELSO is sharing this announcement with our community.
Getinge
US
June 2024 Getinge is providing this letter to US health care providers with more information on Getinge's actions. If you are from outside the US, please see the section for the Outside US market (OUS).
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, 2023. Packaging redesign and revalidation is in-process and Getinge continues to work with the FDA to correct quality-related deficiencies.
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. The FDA designated this a Class II recall. Packaging redesign and revalidation is in-process.
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.
May 2024. If you are a health care provider outside the US, please refer to this letter with more information relating to the US FDA's May 8, 2024 letter.
On September 29th, 2023, the European Commission decided to extend the exemption to supply HLS- and PLS-Sets in derogation from the conformity assessment procedure to the European Union Market based on Art. 59 para. 3 (EU) 2017/745 until September 30th, 2024.
Getinge has submitted updated HLS and PLS packaging documentation to the Notified Body. Please refer to this Getinge webpage for more information relating to the European Union Market.
Medtronic
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.
Abbott
Due to the increased demand for oxygenators, Abbott has partnered with its supplier, Eurosets, and has increased production of polymethylpentene (PMP) fiber oxygenators to alleviate market pressures and support all patients requiring these life saving devices.
Our portfolio of cardiopulmonary support devices is readily available for ordering. These include:
Being well positioned with global reach and relationships to leverage improved production times, and with our experience in quickly and effectively ramping up supply (as seen during the COVID-19 pandemic), we are confident we can deliver products to all hospitals.
Reach out to your local Abbott representative for more information on our product offerings, or contact us at mcscustomerservice@abbott.com
*AMG PMP Adult, Pediatric, Infant Oxygenators and Oxygenator Holder are manufactured by Eurosets s.r.l. and distributed by Abbott.
LivaNova PLC
On January 8, 2024, LivaNova PLC announced that it will commence immediately with an orderly wind down of the Advanced Circulatory Support (ACS) Business Unit to increase the Company’s strategic focus on its core Cardiopulmonary (CP) and Neuromodulation Business Units. The wind down is anticipated to be complete by the end of 2024. The Company will retain all ACS standalone cannulae products and related accessories, including ProtekDuo™, transseptal (TandemHeart™), arterial and venous cannulae, along with corresponding insertion kits, which will all be transitioned into the CP Business Unit product portfolio during the first quarter of 2024. Operations and service for other ACS product lines, including LifeSPARC™ and Hemolung™ Systems, will be discontinued by the end of the year. The Company expects to support scheduled service for the LifeSPARC and Hemolung platforms through the end of 2024. Full press release available on the LivaNova website.
ELSO Activities
ELSO continues to engage with our community on equipment availability and other updates. In June 2023, ELSO published the results of a survey conducted in response to an early FDA recall notice from over 260 centers. Survey results are available below:
ELSO Equipment Recall Survey Results