Z-2224-2019 Class I Terminated
FDA device recall Z-2224-2019 was initiated by Edwards Lifesciences, LLC on July 9, 2019 and is designated Class I. 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 durin… The recall status is terminated (terminated September 15, 2020). Affected quantity: 362 units.
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
- 362 units
Product Description
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
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