Z-1831-2024Class II

CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system

Name: Z-1831-2024 CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system
Creator: Maquet Medical Systems USA
Published: 2024-04-15
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2024-04-15 / Open, Classified

FDA source

Maquet Medical Systems USA began a recall of CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system on 2024-04-15. FDA classified it as Class II and gives the reason as "The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1831-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-15
Posted: 2024-05-16
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
FDA root cause: Under Investigation by firm
Action: Consignees received an "URGENT MEDICAL DEVICE - Removal" email, dated 4/15/2024, notifying them of this recall event. Consignees are asked to examine their inventory to identify if they possess any affected devices and all consignees are asked to return the provided Response Form via email to identify where affected devices are located. Consignees that report having any affected devices will be contacted by Getinge to arrange for return of the affected device to upgrade the system's sensor panel and perform testing to ensure that leakage current is within specifications. Technical Support can also be contacted at 888-943-8872 (option 4, option 2, option 1) Monday through Friday between 8:00 AM and 6:00 PM EST to make service arrangements. Consignees are asked to not use affected devices for any additional patients until it has been cleared by the MCP/Getinge system check, repaired, or replaced. The provided recall notice is to be forwarded to users of the CARDIOHELP-i system and if the device was further distributed.
Quantity in commerce: 148 units (US: 5; OUS: 143)
Distribution: US Nationwide distribution in the states of NJ & TX.
Product codes and lots: Part No. 70104.8012 and 70104.8012R; UDI-DI: 04037691658384; Serial no. 90410021, 90410029, 90410165, 90410254, 90410255, 90410024, 90410025, 90410026, 90410028, 90410030, 90410031, 90410034, 90410035, 90410036, 90410043, 90410044, 90410045, 90410046, 90410047, 90410048, 90410049, 90410050, 90410051, 90410052, 90410053, 90410054, 90410055, 90410056, 90410057, 90410058, 90410059, 90410060, 90410061, 90410062, 90410063, 90410064, 90410065, 90410067, 90410068, 90410069, 90410070, 90410071, 90410072, 90410073, 90410074, 90410075, 90410076, 90410077, 90410078, 90410079, 90410080, 90410081, 90410082, 90410084, 90410085, 90410086, 90410087, 90410088, 90410089, 90410091, 90410093, 90410094, 90410095, 90410096, 90410097, 90410098, 90410099, 90410100, 90410101, 90410102, 90410103, 90410104, 90410105, 90410106, 90410107, 90410108, 90410109, 90410110, 90410111, 90410112, 90410113, 90410114, 90410115, 90410116, 90410117, 90410118, 90410119, 90410120, 90410121, 90410122, 90410123, 90410124, 90410125, 90410126, 90410127, 90410130, 90410131, 90410132, 90410133, 90410134, 90410135, 90410136, 90410137, 90410138, 90410139, 90410140, 90410141, 90410142, 90410143, 90410144, 90410146, 90410147, 90410148, 90410149, 90410151, 90410152, 90410153, 90410154, 90410155, 90410156, 90410157, 90410158, 90410159, 90410160, 90410161, 90410162, 90410163, 90410166, 90410167, 90410168, 90410169, 90410170, 90410172, 90410173, 90410174, 90410175, 90410176, 90410177, 90410178, 90410179, 90410180, 90410181, 90410182, 90410183, 90410184, 90410185, 90410186, 90410187.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-16

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)