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

• 
  Reason
• 
  Affected products

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