HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
HeartMate 3 LVAS Implant Kit |
More than 10 numbers, contact manufacturer. |
106524US |
HeartMate 3 System Controller |
More than 10 numbers, contact manufacturer. |
106531US |
HeartMate 3 System Controller Low Flow 2.0 |
More than 10 numbers, contact manufacturer. |
106531LF2 |
Issue
Abbott is informing customers about the potential for marginally lifted User Interface (UI) membranes that users may observe or may have observed in a limited number of HeartMate 3 System Controllers. If the UI membrane is lifted, in certain circumstances when the controller is exposed to water, there is a potential for water ingress into the HeartMate 3 System Controller. Water ingress has the potential to result in problems with the LED display or unresponsive buttons.
Recall Start Date: June 28, 2024
Additional information
Details
| Abbott Medical |
| 6035 Stoneridge Drive, Pleasanton, California, United States, 94588 |
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