Health product recall

Merlin Patient Care System - Programmer Software

Last updated

Summary

Product
Merlin Patient Care System - Programmer Software
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Merlin Patient Care System - Programmer Software version v25.3.x or earlier 3330 VER 25.2.4 3330 VER 24.4.4 3330 VER 18.2 3330 VER 24.6.4 3330 VER 24.3.4 3330 VER 17.2.1 3330 VER 23.0.4 3330 VER 25.0.4 3330 VER 25.3.4 3330 VER 24.2.4 3330 VER 20.0.1.2 3330 VER 24.5.4

Issue

Abbott is notifying customers of the potential for programmer software (Merlin pcs) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality, therapy delivery, and longevity remain normal and within specifications. Voltage measurements and ERI (elective replacement indicator), which is based on direct voltage measurement, remain accurate.

Recall start date: June 16, 2022

Additional information

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

St. Jude Medical, Cardiac Rhythm Management Division

15900 Valley View Court, Sylmar, California, United States, 91342

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64306