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Health Canada Medical devices

AMPLATZER STEERABLE DELIVERY SHEATH

Issued November 19, 2021
Issue
The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product-related customer training) to reduce the potential for air ingress. Recall start date: 2021-11-09
Hazard description
Labelling and packaging
Product
Product name
AMPLATZER STEERABLE DELIVERY SHEATH
Reference
ID
RA-63641