HVAD Implant Kit
Brand(s)
Last updated
Summary
Product
HVAD Implant Kit
Issue
Medical devices - Performance
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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