Quick summary
Quick summary: HVAD Implant Kit.
Public recall detail
HVAD Implant Kit
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: HVAD Implant Kit.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandHeartware Inc.
ProductHVAD Implant Kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64201
Affected products
ProductHVAD Implant Kit
LotMore than 10 numbers, contact manufacturer.
Model1101 1102 1103 1104 1205 1104CA-CLIN
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHVAD Implant Kit
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesHeartware Inc. 14400 Nw 60th Avenue, Miami Lakes, Florida, United States, 33014
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64201
Background{}
CompaniesHeartware Inc. 14400 Nw 60th Avenue, Miami Lakes, Florida, United States, 33014
AudiencesHealthcare
Source updated2022-05-30
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
Frequently asked questions
Answers based on the official recall notice.
Product images
Official product images from Health Canada.
Starting...
Explore more
Related recalls
Similar recalls and safety notices.