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Heartmate 3 lvas implant kit and heartmate 3 system controller

Official notice

30 Jul 2024

MediumHealth Canada

An official Health Canada notice concerns Heartmate 3 lvas implant kit and heartmate 3 system controller. 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 Published 2024-07-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75837

Official notice

2024-07-30

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75837

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Affected products

Product 1

Affected products - HeartMate 3 LVAS Implant Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 106524US

Product 2

Affected products - HeartMate 3 System Controller, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 106531US

Product 3

Affected products - HeartMate 3 System Controller Low Flow 2.0, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 106531LF2

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Abbott Medical, Heartmate 3 Lvas Implant Kit And Heartmate 3 System Controller.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75837

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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