Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information .
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 |
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 |
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
| Thoratec Corporation |
| 6035 Stoneridge Drive, Pleasanton, California, United States, 94588 |
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