Recall archive / FDA device enforcement
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. — FDA record Z-1831-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Reason
- The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
- Classification
- Class II
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 148 units (US: 5; OUS: 143)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1831-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of NJ & TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 22, 2024
- Recall initiation date
- Apr 15, 2024
- Center classification date
- May 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.