Edwards Commander Delivery System (2019-03-01)

Starting date:

March 1, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-69708

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

Edwards Commander Delivery System

Reason

Edwards has received reports of balloon tears occurring during the valve alignment step with the commander delivery system. The observed complaint rate for this issue is approximately 0.14% based on the global experience with the device. The incidence of serious events related to this issue is approximately 0.02%, typically resulting from inability to fully inflate and/or difficulty removing the delivery system, such as valve malposition with or without embolization, non-target deployment, vascular injury, significant bleeding, and/or need for surgical intervention to prevent permanent injury or death.

Affected products