SynCardia Systems Inc.: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

Is my product affected?

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

• UPC 00858000003121

Check against the official notice below — it lists the full affected range.

What happened

SynCardia Systems Inc. is recalling five Freedom Drivers (5000 Series) used with temporary total artificial heart systems. The devices were distributed in the United States to Virginia and Arizona. The affected units have serial numbers 5002, 5005, 5008, 5009, and 5010.

The Main Printed Circuit Board Assembly in these devices may fail and cause the Freedom Driver to stop working without triggering any visual or audible alarms. This failure could result in loss of the life-sustaining heart support function. The source does not specify what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.

Details from the source

Reason for recall: The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function. Distribution: US distribution to Virginia and Arizona. Quantity: 5 Lot/code info: S/N 5002  UDI (01)00858000003121(21)5002 S/N 5005  UDI (01)00858000003121(21)5005 S/N 5008  UDI (01)00858000003121(21)5008 S/N 5009  UDI (01)00858000003121(21)5009 S/N 5010  UDI (01)00858000003121(21)5010

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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