Maquet Medical Systems USA CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
UDI Code: 04058863074863 (CARDIOHELP-I US), 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.
Products Sold
UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.
Maquet Medical Systems USA is recalling CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used t due to Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default setting. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
Recommended Action
Per FDA guidance
Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device- Correction Customer Letter to US consignees issued on 11/6/23 via express mail. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected CARDIOHELP-i in your inventory. " Please review, download, and print the updated IFU for these products at: https://us.getinge.com/l/950532/2023-10-13/ppb1d2 " Please remove and destroy any previous versions of the IFU at your facility. " As noted in the Key User Functions section of the IFU: " Before beginning the application, ensure that the selected warning and alarm limits, as well as interventions, are suitable and safe for the patient and the current situation. " Before beginning the application, check every intervention selected by simulating an alarm condition. " Should you have any questions or need additional copies of the IFU, please contact Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). " Please forward this information to all current and potential CARDIOHELP-i users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM (Page 5) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to CardiohelpIFU2023.qrc@getinge.com or by faxing the form to 1- 800-861-0842. Type of Action by Getinge: The corrected IFU for the CARDIOHELP-i Heart Lung Support System is available at the web link included in this letter. Getinge will also send a hard copy of the IFU to those customers who request one.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026