CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Cardiohelp-i System recalled by Maquet Medical Systems U
Maquet Medical Systems U is recalling Cardiohelp-i System, distributed nationwide in the US. The recall was initiated on 15 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1831-2024
- FDA event ID
- 94450
- Recalling firm
- Maquet Medical Systems U, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2024
- FDA classified
- 16 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 15 Apr 2024 | Recall initiated by company | |
| 16 May 2024 | Classified by FDA | +31 days |
| 22 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Where it was distributed
US Nationwide distribution in the states of NJ & TX.
Questions about this recall
Is Cardiohelp-i System recalled?
Yes. Maquet Medical Systems U recalled Cardiohelp-i System on 15 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1831-2024.
Why was it recalled?
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of NJ & TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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