HeartWare Ventricular Assist System — recall 58148
Health Canada — Medical Devices · Canada · 2018-09-28 · Type II
As described by Health Canada — Medical Devices: HeartWare Ventricular Assist System - HeartWare Controller (2018-08-29)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: 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.
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