Z-0555-2024Class II

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump...

Name: Z-0555-2024 CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump...
Creator: Maquet Medical Systems USA
Published: 2023-11-06
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-11-06 / Open, Classified / root cause: labeling and UDI

FDA source

Maquet Medical Systems USA began a recall of CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for... on 2023-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0555-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2023-12-14
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0555-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0555-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-14

Product code DTQ

K133598Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2014-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)