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# Safety Alert Updates Risks with SynCardia Heart Device
- URL: https://www.fdaweb.com/safety-alert-updates-risks-with-syncardia-heart-device/
- Published: 2017-09-25T12:00:00.000Z
- Updated: 2026-09-14T22:52:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139698

FDA has updated a 2016 safety alert to transplant surgeons and cardiologists about additional data that continue to indicate that there is a higher mortality rate for a subgroup of patients requiring pre-implant circulatory rescue interventions when using SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System, as compared to the previous driver, the Circulatory Support System console. Interim [results](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma%5Fpas.cfm?t%5Fid=471784&c%5Fid=2246&ref=fdaweb.com) reflect a higher three-month mortality rate for the subgroup compared to those using the CSS Console. “The mortality rates for patients who did not require pre-implant circulatory rescue interventions continued to be similar for the C2 Driver System compared to the CSS Console,” the alert says. “In addition, interim results continue to show a higher neurological adverse event rate in the first three months post-implant for patients initially supported with the C2 Driver System compared to patients initially supported with the CSS Console. This rate is attributed mostly to the difference in the rate of cerebrovascular accidents between the two groups.”