FDANovember 13, 2023device
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
maquet medical systemsmaquetmaquet medical
UPCs
0405886307486304037691658384
Recall history
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