14 Feb 2025, FDA issued a recall about risk of guidewire tip, indwelling central venus line or other medical devices coming into contact with the Impella RP, potentially causing a damage.
Abiomed highlights potential risk of interaction between guidewire tips, central venous lines, or other devices and the inlet of the Impella pumps RP or RP flex during insertion, adjustment, or removal...
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Tags: impella RP, impella RP flex, FDA, Alert, guidewire, central venous line, fiberoptic sensor, Placement Signal Not Reliable, alarm, Pump stoppage, Impella Stopped, restart.
