Health product recall

Heartmate Touch Communication System

Last updated

Summary

Product
Heartmate Touch Communication System
Issue
Medical devices - Performance issue
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 Touch Communication System

All Lots.

HMT1100
HMT1100-R

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Thoratec Corporation

6035 Stoneridge Drive, Pleasanton, California, United States, 94588

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74125

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