Z-0595-2024Class III

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

Name: Z-0595-2024 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump...
Creator: Maquet Medical Systems USA
Published: 2023-11-14
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-11-14 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Medical Systems USA began a recall of CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for... on 2023-11-14. FDA classified it as Class III and gives the reason as "CARDIOHELP-i System was not properly tested to measure leakage current". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0595-2024
Classification: Class III
Status: Open, Classified
Initiated: 2023-11-14
Posted: 2024-09-30
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: CARDIOHELP-i Heart Lung Support System: 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 (up to six hours). Product REF Numbers: 701072780; 701048012
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: CARDIOHELP-i System was not properly tested to measure leakage current
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device Correction Letter to U.S, consignees November 14, 2023 via FedEx. 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. " 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 4) 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 1-800-530-6084. " If you report having any affected CARDIOHELP-i devices, a local Getinge representative will contact you to arrange a system check of the device to ensure that leakage current is within specifications. " Affected CARDIOHELP-i devices are not requested to be returned and can be used as usual. " 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. Type of Action by Getinge: Getinge has identified the issue to be related to a supplier using an incorrect drawing to produce a tool used to measure leakage current of the CARDIOHELP-i. This issue has been corrected by the supplier. MCP/Getinge will contact you to arrange for a MCP/Getinge service technician to perform a system check of any affected device you report to confirm leakage current is within specifications (IEC 62353). If a system fails the performed test, the MCP/Getinge service technician will replace the system s sensor panel for you. MCP/Getinge service may have already performed the required system check of your device during a past preventative maintenance. MCP/Getinge will check service records to confirm. MCP
Quantity in commerce: 1594 units
Distribution: Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen
Product codes and lots: UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2024	Class III	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-20

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)