Maquet Medical Systems USA is voluntarily recalling Venous probe connection cables used with the Cardiohelp-i System, the FDA said on Nov. 13, 2023. The firm initiated the recall after receiving complaints of breaks in the cable's insulation, shielding, or wires.
How to tell if you have it
- Brand: Maquet Medical Systems
- Product: Venous probe connection cable used with the Cardiohelp-i System
- REF: 701069333 and 701048804
- Part numbers: 701072780 and 701041802
- UDI-DI: 04058863074863 and 04037691658384
- Serial numbers: All up to and including 90413927
The hazard
Fracture of the venous probe cable may influence the management of extracorporeal support. Patients 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.
Context
GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Other recent recalls include the Maquet Cardiohelp-i System Recall dated April 15, 2024, and the Maquet BEQ-HLS 7050 Recall dated Jan. 16, 2024. Additional similar product recalls include the Maquet Bubble Sensor Recall on Jan. 9, 2026, the Medline Namic Preceptor Manifold Recall on March 24, 2026, and the Hamilton Medical IntelliCuff Recall on May 22, 2026.