Health product recall

HEARTMATE TOUCH COMMUNICATION SYSTEM

Last updated

Summary

Product
HEARTMATE TOUCH COMMUNICATION SYSTEM
Issue
Medical devices - Software defect
What to do
Contact the manufacturer if you require additional information.

Affected products

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

Issue

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

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

UNIED STATES

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63555

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