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5000 Series Freedom Drivers. Freedom Driver System for… recallZ-0659-2017 · SynCardia Systems Inc. · initiated Oct 21, 2016

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from SynCardia Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On 10/21/16 customers were notified by phone. Customers were informed that patients who were being supported by affected Drivers must be switched to unaffected Drivers. The firm will provide unaffected Freedom Drivers to replace the affected Drivers. Affected Drivers must be return to the firm. Instructions for return provided, and Acknowledgment Form must be completed. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, LLC 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time Hotline 24/7 866-771-9437 www.syncardia.com On 10/27/16 customer notification letters were sent. The letter provided instructions on how to recognize the device could fail. The patient and caregiver will recognize that an affected Driver is failing because the Freedom Driver will stop pumping without generating any sound or any visual or audible alarms. When functioning, the Freedom Driver exhibits a distinctive pumping sound; when it stops pumping the lack of sound is noticeable. Generally, if the Freedom Driver function is interrupted, a visual and/or audible alarm will occur. However, as a result of this component failure, when affected Freedom Drivers stop functioning, there will be no visual or audible alarms, and no pumping sound. Actions to Be Taken by The Customer/User SynCardia has provided unaffected Freedom Drivers to the two hospitals to replace the affected 5000 series Drivers. All patients with affected Freedom Drivers have undergone the exchange and received unaffected Drivers. The hospitals have returned all the affected Freedom Drivers to SynCardia. The hospitals are requested to complete the Recall Acknowledgement and Receipt Form below and return to SynCardia.

Recall details

Recall number
Z-0659-2017
Status
Terminated
Initiated by the company
Oct 21, 2016
Recalling firm
SynCardia Systems Inc.
Quantity
5
Product code
LOZ
FDA submissions
P030011
Distribution
US distribution to Virginia and Arizona.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

8 devices cleared under P030011 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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