Certitude Delivery System and any associated Multipacks Models — Class I medical device recall Z-0293-2018
Terminated recall by Edwards Lifesciences, LLC, reported 2018-01-17, distributed in AK, HI, ID, NM, RI, SD, WY. A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of
| Recall number | Z-0293-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2018-01-10 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-09-13 |
| Distributed | AK, HI, ID, NM, RI, SD, WY |
| Countries outside the US | MX |
| Quantity | 1,730 units |
| Reason classes | device malfunction |
| Lot numbers | 60677270, 60677343, 60677653, 60678007, 60678033, 60678035, 60678040, 60679106, 60685057, 60689105, 60693311, 60697333, 60699067, 60703355, 60703356, 60703357, 60704423, 60708907, 60712982, 60718006, 60718007, 60718977, 60718978, 60718979, 60724851, 60724852, 60724853, 60724854, 60724855, 60724856, 60724857, 60724858, 60724859, 60724860, 60724861, 60724862, 60724863, 60724864, 60724865, 60724866 and 460 more |
| Model numbers | 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0293-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.