FDAFDA · Food and drugs·Recall number Z-2227-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Published August 28, 2019 · Recall initiated: July 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
- Lot
- All Lots
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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