Recall Z-2731-2015— SynCardia Systems Inc.
Class I · Terminated
Class I FDA medical device recall by SynCardia Systems Inc., initiated 2015-08-06, terminated 2015-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.. Reason: SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function..
- Recalling firm
- SynCardia Systems Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-08-06
- Terminated
- 2015-11-04
- Firm location
- Tucson, AZ, United States
Product description
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
Reason for recall
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.
Data sourced from openFDA. This site is unofficial and independent of the FDA.