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Health Canada Medical devices

Impella CP With SmartAssist and Impella 5.5 With SmartAssist

Issued September 5, 2024
Issue
Abiomed has determined there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with shockwave coronary intra-vascular lithotripsy catheter. Recall Start Date: September 3, 2024
Hazard description
Device compatibility
Product
Product name
Impella CP With SmartAssist and Impella 5.5 With SmartAssist
Reference
ID
RA-76002