Health product recall

HeartWare Ventricular Assist System - Battery Charger And AC Adapter (2020-01-28)

Starting date:
January 28, 2020
Posting date:
February 28, 2020
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-72427

Last updated: 2020-03-06

Affected Products

  1. HeartWare Ventricular Assist System - HeartWare Battery Charger
  2. HeartWare Ventricular Assist System - Battery Charger AC Adapter

Reason

Medtronic HeartWare is informing customers 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. Power to the controller and to the HeartWare HVAD pump will continue to be maintained if a battery charger AC adapter is mistakenly inserted into a controller power port and a secondary power source also is connected to the controller. The battery charger AC adapter is not intended to be attached to a controller power port.

If circuits within the controller are damaged as the result of this issue, it will be necessary to exchange the controller to restore controller-to-battery communications and resolve alarms. A controller exchange could lead to patient harm due to pump stoppage. Temporary pump stoppage could lead to exacerbation of heart failure symptoms and/or symptoms related to hypoperfusion ranging from mild weakness to dizziness, anxiety, nausea, lightheaded/loss of consciousness, or death. The severity of harm is dependent on the patient's cardiac status.

Affected products

A. HeartWare Ventricular Assist System - HeartWare Battery Charger

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1610CA

Companies
Manufacturer
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES

B. HeartWare Ventricular Assist System - Battery Charger AC Adapter

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1640CA

Companies
Manufacturer
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES