HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller
Brand(s)
Last updated
Summary
Product
HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller
Issue
Medical devices - Labelling and packaging
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 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| Abbott Medical |
| 6035 Stoneridge Drive, Pleasanton, California, United States, 94588 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75837
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