Z-2226-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 9, 2019
- Termination Date
- September 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2579 Units
Product Description
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Reason for Recall
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
Distribution Pattern
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
Code Information
All Lots