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 number

Z-0555-2024

Recalling firm

Maquet Medical Systems USA

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)

Status

Open, Classified

Initiated

2023-11-06

Posted

2023-12-14

Terminated

not on file

Reason

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

Root cause

Labeling design

Action

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.

Quantity

1595 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, R¿union, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Lot, serial or model codes

UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.

510(k) numbers

["K133598"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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