Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
Brand(s)
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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