medical Class II Updated 2023-12-27

Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804)

Recalled Product

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927
View official government recall

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