HeartWare Ventricular Assist System - HeartWare Battery Charger (2018-11-26)

Starting date:

November 26, 2018

Posting date:

January 8, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68704

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  Reason
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  Affected products

Affected products

HeartWare Ventricular Assist System - HeartWare Battery Charger

Reason

HeartWare, now a part of Medtronic, has been notified by an outside vendor that a quantity of HVAD Battery Charger units may have been manufactured with an incorrect circuit component. This subset may exhibit one or more of the battery charging bays not fully charging the battery and/or battery charger indicators (led) not lighting.

Affected products