Health product recall

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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