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Recalls from Edwards Lifesciences, LLC

Recalls from Edwards Lifesciences, LLC filed with the FDA, USDA FSIS, CPSC or NHTSA, newest first. Company page 2 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Agency
Risk level
Status
Date
Sold in

1 recall that day

Edwards Lifesciences Commander M Delivery System

The Edwards Commander M Delivery System may have a manufacturing issue causing cardiovascular balloon rupturing.

High risk, FDA, Manufacturing problem

1 recall that day

Edwards EVOQUE Tricuspid Delivery System

The Edwards Evoque tricupid delivery system may have compromised functionality, which could affect the valve replacement.

Moderate risk, FDA, Labeling error