Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers

Update: May 8, 2024 

Today, the FDA issued a Letter to Health to Care Providers to alert health care providers and facilities about continued safety and quality concerns with the Getinge cardiovascular medical devices.

The FDA recommendations below have not changed.

June 9, 2023

The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation.  

On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy Reservoirs due to potentially compromised packaging sterility that may result in the risk of infection/harm to the patient.

The FDA is issuing this letter to help ensure that health care providers and facilities are aware of the manufacturer's recall notice and have information about alternative devices.

Recommendations

The FDA recommends health care providers and facilities who use Getinge/Maquet Quadrox Oxygenators and Venous Hardshell Cardiotomy Reservoirs:

• Review the recall notice from Getinge/Maquet for all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs.
  • Check your inventory to determine if you have any Quadrox Oxygenators or certain Venous Hardshell Cardiotomy Reservoirs.
  • 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. Monitor patients for the following signs and symptoms, and, if detected, treat the patient according to clinical protocols: inflammation, infection, sepsis, and ischemia.
• 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.
  • FDA-cleared oxygenators for use in cardiopulmonary bypass (CPB) circuit (search Product Code DTZ)
  • FDA-cleared oxygenators for use in extracorporeal membrane oxygenation (ECMO) circuit (search Product Code BYS)
• Report any issues with oxygenators to the FDA. See "Reporting Problems with Your Device" below.

Background

Oxygenator devices are blood-gas exchangers used to provide physiological gas exchange for up to 6 hours during cardiopulmonary bypass 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 cardiopulmonary bypass procedures for up to 6 hours.

FDA Actions

The FDA will continue to work with health care providers and facilities to assist with challenges related to available options for oxygenator devices.

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

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

Reporting Problems to the FDA

The FDA is interested in hearing from health care providers and facilities who have trouble obtaining medical devices, including oxygenators. Email the FDA at deviceshortages@fda.hhs.gov.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Affected Devices

The following Medical Device Recall Database entries for Getinge/Maquet Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs include Unique Device Identifier (UDI) information provided by the manufacturer. The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. UDI information can be found in the "Code Information" section:

• Quadrox i Adult
• Quadrox i Small Adult
• Quadrox i Pediatric
• Quadrox i Neonatal
• Quadrox iD Adult
• Quadrox iD Pediatric
• Quadrox iR
• Venous Hardshell Cardiotomy Reservoir

For more information on UDI, please visit Unique Device Identification System (UDI System).

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).