medical Class I Updated 2019-08-28

Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAP

Recalled Product

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

Hazard / Issue

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

Issued by

FDA

Affected States: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS
Lot/Code Info: All Lots
View official government recall

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