Health product recall

Heartware Ventricular Assist System – Heartware Battery

Brand(s)
Last updated

Summary

Product
Heartware Ventricular Assist System – Heartware Battery
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Heartware Ventricular Assist System – Heartware Battery

All lots.

1650DE

Issue

Medtronic is informing customers of product performance issues related to the Heartware Ventricular Assist Device (HVAD) system batteries. Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified within some batteries that can cause the battery to fail to deliver power, 2) an interaction between the battery software configuration and the battery circuit board can cause electrical faults within some batteries. Manufacturer is taking action to improve battery performance and address quality issues. this notification provides information on the two battery performance issues as well as patient management recommendations. In both situations, it is important that patients respond to all battery related alarms. if both batteries connected to an HVAD controller malfunction, a pump stop event could occur due to controller loss of power. a malfunction of a single battery that is connected to the HVAD controller will cause the controller to rely solely on the second power source to power the pump. No batteries are being requested to be returned or exchanged as part of this communication.

Recall start date: June 28, 2022

Additional information

Details
Original published date: 2022-07-06
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Heartware Inc.

14400 Nw 60th Avenue, Miami Lakes, Florida, United States, 33014

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64335