ABIOMED REMOVES CERTAIN IMPELLA CP DUE TO FAILED QUALITY INSPECTIONS. FDA RECALL, AUGUST 2024.

 Abiomed sent customers voluntary recall of removal in May 2024.

9 Impella CP of a single lot failed inspection but were mistakenly distributed.

Expanded and detailed information in this video:

Source FDA:

https://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-recall-abiomed-removes-certain-impella-cp-smartassist-systems-due-failed-quality