Health product recall

Heartware Ventricular Assist System- Controller/ Controller Kits, AC Adapter, DC Adapter, and Battery Pack (2018-05-07)

Starting date:
May 7, 2018
Posting date:
June 1, 2018
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-66936

Affected products

A. Heartware Ventricular Assist System- Controller/ Controller Kits

B. Heartware Ventricular Assist System- AC Adapter

C. Heartware Ventricular Assist System- DC Adapter

D. Heartware Ventricular Assist System- Battery Pack

Reason

Manufacturer is providing this notification to inform customers of the potential for a transient interruption of the electrical connection between an HVAD system power source (battery, ac adapter, or dc adapter) and the HVAD controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones ("beeping"). This interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller's power source socket, and typically lasts 1-2 seconds.

Unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or AC/DC connectivity at the time of the audible tone. A critical battery alarm may also be momentarily displayed due to this phenomenon.

Affected products

A. Heartware Ventricular Assist System- Controller/ Controller Kits

Lot or serial number

All lots.

Model or catalog number

1407CA

1420

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES


B. Heartware Ventricular Assist System- AC Adapter

Lot or serial number

All lots.

Model or catalog number

1430CA

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES


C. Heartware Ventricular Assist System- DC Adapter

Lot or serial number

All lots.

Model or catalog number

1440

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES


D. Heartware Ventricular Assist System- Battery Pack

Lot or serial number

All lots.

Model or catalog number

1650DE

Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES