Z-2227-2019 Class I Terminated
FDA device recall Z-2227-2019 was initiated by Edwards Lifesciences, LLC on Jul 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… The recall status is terminated (terminated Sep 15, 2020). Affected quantity: 1754.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2019
- Initiation Date
- Jul 9, 2019
- Termination Date
- Sep 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1754
Product Description
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2227-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026