Official recall record
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-06
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04058863074863
- Brand on record
- Maquet Medical Systems USA
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-10-12 · US FDA — Medical Devices
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli - 2023-11-13 · US FDA — Medical Devices
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an
Other recalls from this brand
- 2023-11-13 · US FDA — Medical Devices
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 70 - 2023-05-18 · US FDA — Medical Devices
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
All 8 official recall notices naming Maquet Medical Systems USA on this site →
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