Summary: The U.S. Food and Drug Administration (FDA) has alerted health care providers about potential risks associated with the use of Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs manufactured by Getinge/Maquet. The company issued an Urgent Medical Device Removal notice due to concerns about compromised packaging sterility, posing a risk of infection/harm to patients. The FDA recommends reviewing the recall notice, checking inventory for affected devices, and not using them unless already in use. For new procedures, alternative FDA-cleared oxygenators should be considered. The FDA is actively working with Getinge/Maquet to monitor adverse events related to the recall and encourages health care providers to report issues promptly. The unique device identifiers for affected products are listed in the Medical Device Recall Database. The FDA will provide updates as new information becomes available and encourages reporting of device shortages or adverse events.
December 28, 2023