# FDA recall Z-0293-2018

> **Edwards Lifesciences, LLC** · Class I · device recall initiated 2017-07-21.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0293-2018
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2018-01-17
- **Termination date:** 2019-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Draper, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2018

## Citation

> AI Analytics. FDA recall Z-0293-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0293-2018. Source: US FDA. Licensed CC0.

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