Health product recall

Heartware Ventricular Assist System - HVAD Implant Kit

Brand(s)
Last updated

Summary

Product
Heartware Ventricular Assist System - HVAD Implant Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Heartware Ventricular Assist System - HVAD Implant Kit More than 10 numbers, contact manufacturer. 1104

Issue

Controller driveline cover of HVAD system may become hardened, creating difficulty or an inability to slide the cover back to access the drive line to control the connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop.

Recall start date: November 29, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Heartware Inc.

14400 Nw 60th Avenue, Miami Lakes, Florida, United States, 33014

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72340