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Health Canada Medical devices

Impella Systems

Issued March 6, 2024
Issue
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Recall start date: February 26, 2024
Hazard description
Labelling and packaging
Product
Product name
Impella Systems
Reference
ID
RA-75182