Official recall record
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-13
- 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
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
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.
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 - 2023-11-06 · US FDA — Medical Devices
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through
Other recalls from this brand
- 2023-11-06 · US FDA — Medical Devices
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blo - 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 →