Health product recall

Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems

Last updated

Summary

Product
Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
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 catalogue number

Heartmate II LVAS - Implant Kit

More than 10 numbers, contact manufacturer.

103695-CAN
106015

Heartmate II LVAS - Implant Kit With Sealed Grafts

More than 10 numbers, contact manufacturer.

104911

Heartmate 3 LVAS Implant Kit

More than 10 numbers, contact manufacturer.

106524
106524US

Issue

Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and Heartmate II™ LVAS. Significant EOGO will manifest clinically as as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the Heartmate LVAS to provide adequate hemodynamic support.

Recall start date: February 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Thoratec Corporation
6035 Stoneridge Drive, Pleasanton, California, United States, 94588
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75183

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