FDA Flags Getinge/Maquet Recall of Oxygenator Devices

The US Food and Drug Administration (FDA) is reminding healthcare providers and facilities about the recent recall of certain oxygenators used for extracorporeal circulation.

On May 18, Getinge/Maquet issued an urgent medical device removal notice alerting users not use any Quadrox oxygenator and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to a potential sterility issue with the packaging that could result in the risk for infection or patient harm, the FDA says in a letter to healthcare professionals.

Oxygenators are used to provide physiological gas exchange for up to 6 hours during cardiopulmonary bypass (CPB) procedures, or for more than 6 hours during extracorporeal membrane oxygenation (ECMO) procedures.

The venous hardshell cardiotomy reservoir is used to collect, store, and filter blood in extracorporeal circulation in CPB procedures for up to 6 hours.

The FDA says it issued the letter today to “help ensure that health care providers and facilities are aware of the manufacturer’s recall notice and have information about alternative devices.”

The FDA recommends that providers and facilities who use Getinge/Maquet Quadrox oxygenators and venous hardshell cardiotomy reservoirs take the following actions:

  • Review the recall notice from Getinge/Maquet for all affected products.

  • Check inventory for any recalled product.

  • Do not use these devices unless they are already in use.

  • If a Quadrox oxygenator or specified venous hardshell cardiotomy reservoir is already in use, these devices may continue to be used. Patients should be monitored for inflammation, infection, sepsis, and ischemia, and, if detected, treated according to clinical protocols.

  • For new extracorporeal circulation procedures, use alternative device(s) instead of Getinge/Maquet Quadrox oxygenators and certain venous Hardshell cardiotomy reservoirs.

  • Look for other manufacturers or suppliers of oxygenators to determine if alternatives are appropriate. The FDA letter provides links to FDA-cleared oxygenators for use in CPB circuit and ECMO circuit.

The FDA says it will continue to work with clinicians and facilities to assist with “challenges” related to available options for oxygenator devices.

The FDA is also working with Getinge/Maquet to monitor for any adverse events related to their recall.

Healthcare professionals and facilities that have trouble obtaining medical devices, including oxygenators, should alert the FDA by email at [email protected].

Adverse events with these or other devices should be reported to the FDA through MedWatch, its adverse event reporting program.

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