Medical Device Network

FDA issues alert for health care providers after oxygenator device recall

The FDA is alerting healthcare providers about product recall amid concerns of compromised packaging sterility.

The US Food and Drug Administration (FDA) has issued a press release providing recommendations on how to handle the recent recall of Getinge/Maquet’s oxygenators used for extracorporeal circulation.

The move comes after Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs, on 18 May.

Getinge/Maquet recalled the devices due to the possibility of an accessory being improperly placed during packaging, causing creases and damage to the accessory’s sterile pouch as well as potential holes, cracks, dents, and crushed areas in the packaging. Exposure to a non-sterile or potentially non-sterile medical device could result in inflammation, infection, sepsis, and ischemia.

Getinge said it was working with all possible urgency on the redesign and revalidation of a packaging solution, which is anticipated to be available by Q4 2023.

The FDA issued the June 9 letter to help ensure that health care providers and facilities were aware of the manufacturer's recall notice and had information about alternative devices.

The Quadrox Oxygenators are blood-gas exchangers with an integrated heat exchanger. They are used to oxygenate blood, remove carbon dioxide, and adjust blood temperature during cardiopulmonary bypass and open-heart procedures with up to a six hour duration of use.

The Venous Hardshell Cardiotomy Reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on paediatric patients for up to six hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir, such as for thorax drainage, to return the autologous blood to the patient, which was removed from the thorax for the volume exchange.

The extracorporeal membrane oxygenation market has seen high demand for new technologies, products and service offerings since Covid-19, a key driver of growth in the market. The pandemic has highlighted the importance of the technology for patients and driven demand worldwide.

The FDA is recommending that health care providers and facilities review the recall notice and check inventory to determine whether they have any Quadrox Oxygenators or certain Venous Hardshell Cardiotomy Reservoirs. It is advising not to use the devices unless they are already in use. If they are already in use, they can continue to be used but patients must be monitored for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, patients should be treated according to clinical protocol.