Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Recalled by Edwards Lifesciences, LLC Due to The action has been initiated to address reports...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Quantity: 1754
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 12 states: AL, CA, GA, KS, MD, MA, MN, NY, OR, TN, VA, WA
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report