Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usag
FDA device recall Z-0293-2018 · posted 2018-01-10 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- 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.
- Action taken
- Recall notification letters were sent to affected consignees via Fed-Ex on 7/21/2017.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NPT
- Quantity affected
- 1730 units
- Distribution
- United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
- Date initiated
- 2017-07-21
- Date posted
- 2018-01-10
- Date terminated
- 2019-09-13
- Location
- Draper, UT
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