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Heartmate touch communication system

Official notice

18 Aug 2023

Last checked

18 Aug 2023

Medium riskHealth Canada

An official Health Canada notice concerns Heartmate touch communication system. Abbott is notifying customers of a single reported event with Heartmate Touch™ Communication System. During a clinic visit, the Heartmate Touch Communication System in one treatment room connected to the Heartmate Touch Wireless Adapter plugged into the power module in an adjacent treatment room without a user-initiated action or notification to the user. This led to the clinician adjusting settings of another patient without the clinician's awareness. Recall Start Date: August 1, 2023 Published 2023-08-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74125

Official notice

2023-08-18

The hazard

Abbott is notifying customers of a single reported event with Heartmate Touch™ Communication System. During a clinic visit, the Heartmate Touch Communication System in one treatment room connected to the Heartmate Touch Wireless Adapter plugged into the power module in an adjacent treatment room without a user-initiated action or notification to the user. This led to the clinician adjusting settings of another patient without the clinician's awareness. Recall Start Date: August 1, 2023

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

74125

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Affected products

Product 1

Affected products - Heartmate Touch Communication System, Lot or serial number - All Lots., Model or catalog number - HMT1100 HMT1100-R

Risk / hazard

Abbott is notifying customers of a single reported event with Heartmate Touch™ Communication System. During a clinic visit, the Heartmate Touch Communication System in one treatment room connected to the Heartmate Touch Wireless Adapter plugged into the power module in an adjacent treatment room without a user-initiated action or notification to the user. This led to the clinician adjusting settings of another patient without the clinician's awareness. Recall Start Date: August 1, 2023

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

74125

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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