Health product recall

HVAD Implant Kit

Brand(s)
Last updated

Summary

Product
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

HVAD Implant Kit

More than 10 numbers, contact manufacturer.

1101
1102
1103
1104
1205
1104CA-CLIN

Issue

Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically.

Recall start date: April 26, 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-64201

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