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Heartmate touch communication system

Official notice

5 Nov 2021

Last checked

5 Nov 2021

Medium riskHealth Canada

An official Health Canada notice concerns Heartmate touch communication system. Abbott has initiated customer communication following receipt of complaints of the Heartmate touch communication system ('Heartmate Touch') application ('APP') unexpectedly closing or failing to open, which will require the medical facility to have in addition at least one system monitor II. The Heartmate Touch is part of the Heartmate 3 and Heartmate II IVAS and is used in the medical facility for patient monitoring and system programming. There have been no reports of patient injury associated with these complaints. Recall date: 2021-10-25 Published 2021-11-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63555

Official notice

2021-11-05

The hazard

Abbott has initiated customer communication following receipt of complaints of the Heartmate touch communication system ('Heartmate Touch') application ('APP') unexpectedly closing or failing to open, which will require the medical facility to have in addition at least one system monitor II. The Heartmate Touch is part of the Heartmate 3 and Heartmate II IVAS and is used in the medical facility for patient monitoring and system programming. There have been no reports of patient injury associated with these complaints. Recall date: 2021-10-25

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

63555

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Affected products

Product 1

Affected Products - HEARTMATE TOUCH COMMUNICATION SYSTEM, Lot or serial number - Not applicable., Model or catalog number - HMT1100 HMT1100-R

Risk / hazard

Abbott has initiated customer communication following receipt of complaints of the Heartmate touch communication system ('Heartmate Touch') application ('APP') unexpectedly closing or failing to open, which will require the medical facility to have in addition at least one system monitor II. The Heartmate Touch is part of the Heartmate 3 and Heartmate II IVAS and is used in the medical facility for patient monitoring and system programming. There have been no reports of patient injury associated with these complaints. Recall date: 2021-10-25

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

Manufacturer

Not provided

Phone

Not provided

Brand: Thoratec, Heartmate Touch Communication System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63555

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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