Recall Z-0293-2018— Edwards Lifesciences, LLC
Class I · Terminated
Class I FDA medical device recall by Edwards Lifesciences, LLC, initiated 2017-07-21, terminated 2019-09-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.. Reason: A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-07-21
- Terminated
- 2019-09-13
- Firm location
- Draper, UT, United States
Product description
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) or transaortic (TAo) approach to transcatheter aortic valve replacement.
Reason for recall
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.