HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with ad

FDA device recall Z-1427-2020 · posted 2020-03-09 · Open, Classified

Recall details

Recalling firm

Heartware, Inc.

Reason for recall

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

Action taken

Heartware notified customers on about 01/23/2020 via "Urgent Field Safety Notice" letter. Customers were notified of the potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. When this occurs, communication circuits between the battery and the Controller may be damaged. If circuit damage occurs, it will be necessary to exchange the Controller to restore communication between the batteries and Controller. Instructions included to advise patients to carefully follow the guidance provided in the patient manual related to connecting a power source. Pay attention when connecting and disconnecting power supply cables to ensure users verify the correct cable is being connected to their Controller. Patients were instructed to report any persistent, unexpected audible tones to their Clinician for additional instructions. Additional instructions included to ensure all personnel within your organization or any customers if further distributed are notified of this recall. If you have any questions, please contact the Cardiac and Vascular Group Customer Focused Quality at 763-526-2513 or by email to: carlos.j.alfonzo@medtronic.com.

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

5,489 devices total

Distribution

No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, Fr

Date initiated

2020-01-23

Date posted

2020-03-09

Location

Miami Lakes, FL