FDA Device recall Z-2224-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
- FDA Device
- Class I
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class I recall of Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239 by Edwards Lifesciences, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2224-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-07-09 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Edwards Lifesciences |
| Distribution | AL, CA, GA, KS, MA, MD, MN, NY, OR, TN, VA, WA |
Product
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Reason
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
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.