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Terminated

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.

FDA Recall Z-0293-2018 · Posted 2018-01-10

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeNPT
Date Initiated2017-07-21
Date Terminated2019-09-13
Product Quantity1730 units

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.

Firm Action

Recall notification letters were sent to affected consignees via Fed-Ex on 7/21/2017.

Root Cause

Employee error

Distribution Pattern

United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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