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