Recall Z-2224-2019— Edwards Lifesciences, LLC
Class I · Terminated
Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2019-07-09, terminated 2020-09-15. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-07-09
- Terminated
- 2020-09-15
- Firm location
- Irvine, CA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.