Health product recall

HeartWare Ventricular Assist System - HeartWare Controller (2018-08-29)

Starting date:
August 29, 2018
Posting date:
September 28, 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-67828

Affected products

HeartWare Ventricular Assist System - HeartWare Controller

Reason

Controller units may not meet the labeled standard for protection against water or fluid ingress. Specifically, some units have the potential to develop hairline cracks at the power ports of the controller housing. Hairline cracks may allow for water ingress if the patient does not follow the instructions for use and the patient manual, including use of a water-resistant shower bag to help protect the unit.
If a controller develops a hairline crack and is unprotected from water or fluid exposure as described in the IFU, the unit may experience water or fluid ingress. This can lead to varying degrees of controller malfunction, including pump stop.

Affected products

HeartWare Ventricular Assist System - HeartWare Controller

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1407CA
1420

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